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8 Essential Elements of Pharmaceutical Quality Management Systems

If you aren’t following current good manufacturing practices (cGMP), ISO standards, and FDA ICH Q10 guidance, then you’re leaving yourself open to ...

6 Strategies for Successful Biotech Funding

The biotech industry is booming. In 2020, venture biotech funding reached $36.6 billion, according to McKinsey & Company. With the way the ...

10 Top Life Sciences Conferences in 2022

As we look to the calendar year ahead, it's time to plan out your schedule for industry events. Registering for high-quality conferences, whether ...

Qualio as a Force for Good: Year 2 of Improving Healthcare Access for Vulnerable Populations

 

What the FDA's new draft software guidance tells us

November finally saw the release of the FDA's new draft guidance on premarket software submission content.

Qualio dominates Medical QMS category of the G2 Winter Awards 2022

Qualio has continued to build our successful presence on the technology review platform G2 by placing first in 4 key areas in the Medical QMS ...

Ultimate guide to Qualio integrations

Integrations aren't just about making your life easier and your work faster - though of course that's important.

Understanding the Scope of Quality Assurance in the Pharmaceutical Industry

It can be a challenge to maintain a company-wide dedication to quality assurance for therapeutics and pharmaceuticals. When you have a product that ...

How Much Is the FDA Medical Device Registration Fee in 2022?

For the fiscal year of of 2022, the Food and Drug Administration (FDA) medical device registration fee rates increased by 2.5% from 2021. Considering ...

New look, same mission at Qualio

Today we’re excited to share Qualio’s new brand identity.

Creating a Culture of Quality at Synthego

Synthego is a genome engineering company that leverages machine learning, automation, and gene editing technologies to accelerate life science ...

Treating Previously Undruggable Diseases: Dr. Ian Taylor at Arvinas

  Subscribe on any major podcast player. Most likely everyone reading this has been affected by cancer or knows someone who has had cancer. Using ...

Meet Qualio Plus: Sidekick Health Chooses Qualio for Audit-Readiness

Sidekick Health is a software company founded by medical doctors and specialists that operates a gamified digital care platform designed to help ...

What are the Differences in the FDA Medical Device Classes?

If you're getting a replacement heart valve, you want to know the device going in your chest went through a different approval process than a pair of ...

What all medical device founders should know with John Kapitan, CEO of Kapstone Medical

  Subscribe on any major podcast player. Today's guest, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in ...

The Best QMS Software: The Pros and Cons of the 5 Top Options

Life science organizations can select from an extensive range of cloud-based solutions for quality management systems, including ...

4 Things Pharmaceutical Startups Need for Document Management

Imagine this: your pharmaceutical company is close to receiving full FDA approval for your new drug—but then the FDA comes back to you with multiple ...

Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

  Subscribe on any major podcast player. Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell ...

The 9 Core Elements of a Quality Management System

Sound on! Listen to the audio version of this article (read by a real person) here:  Every life science company knows that quality is of the utmost ...

What is FDA Emergency Use Authorization

In recent months, the U.S. Food and Drug Administration (FDA) has used Emergency Use Authorizations (EUA) to accelerate the development and approval ...

Reducing Time to Market for Pharma Companies with Rapid Payer Response

  Subscribe on any major podcast player. Typically, it takes several months for third-parties and consultants in the life sciences industry to get ...

9 Best ISO 13485:2016 Training Programs in 2021

The caliber of your team’s ISO 13485:2016 training has a significant impact on the success and effectiveness of your quality programs. In fact, ...

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

We all know that quality management isn't a "set it and forget it system," but how do you actually make continuous improvement in quality management ...

What is a Device History Record (DHR)?

What is the best way to ensure that your medical device has been built with quality in mind? Many industry-leading medical device manufacturers rely ...

Bring life-saving medical devices to market faster with Qualio Design Controls

The Risks of ISO 9001 Nonconformance

Concerned about ISO 9001 nonconformance? You're not alone. Almost all organizations receive a nonconformance notification at some point. The question ...

6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations

If you've never completed a medical device clinical evaluation report, you're probably concerned with how involved the report needs to be and how ...

What is the Device Master Record (DMR)?

The 21 CFR 820.181 regulation requires all medical device manufacturers to maintain concrete records related to device specifications, quality ...

How to Respond to FDA Warning Letters

What’s the fastest way to ruin a quality manager’s day? Receiving a warning letter from the United States Food and Drug Administration (FDA). ...

3 FDA Design Control Requirements for Medical Device Startups

Did you know that design issues are the largest source of product recalls in the United States?  Poorly designed products pose a serious threat to ...

Rapidly Discovering and Extracting Natural Pharmaceuticals

  Subscribe on any major podcast player. Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform ...

What Is the Unique Device Identification (UDI) System and Why Is it Important?

If you’re preparing to introduce a new medical device to market, labelers must first secure a unique device identifier.  In case you’re unfamiliar, ...

How Long Does the FDA Medical Device Approval Process Take?

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...

Identifying the 4 Most Common Problems With Your CAPA Process

Over the years, we’ve heard from thousands of life sciences startup founders and quality managers. As an industry-leading quality management system ...

5 Major Total Quality Management Principles for Medical Device Startups

What is total quality management (TQM) as it relates to the life sciences industry? A bulletproof TQM strategy outlines the strategies manufacturers ...

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

To ensure that products are safe and effective for use, medical device manufacturers need to follow specific guidelines enforced by the U.S. Food and ...

What is the Global Unique Device Identification Database (GUDID)?

The U.S. Food and Drug Administration (FDA) created the Global Unique Device Identification Database (GUDID) as a labeling resource for medical ...

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

Did you know that the biopharmaceutical industry represents some of the most significant achievements in modern science and technology? When you stop ...

How to Get IEC 60601-1 Approval in 5 Easy Steps

For some medical device startups and scale-ups, achieving International Electrotechnical Commission (IEC) 60601-1 approval is easier said than done. ...

3 Biopharmaceutical Manufacturing Trends to Watch in 2021

Since the advent of modern medicine, biopharmaceuticals have continued to revolutionize the treatment of both longstanding and emerging global ...

Advancing Human Health with Turnkey Biotech Incubator Brazen Bio

  Subscribe on any major podcast player. Have you ever wondered why so many new biotech companies don't survive the first valley of death, which is ...

Qualio now offers industry-leading high availability

Reliable tools are a top priority for life sciences companies. When you’re bringing transformative new drugs, therapeutics, and medical devices to ...

The 13 Essentials of a Quality Plan for Medical Device Companies

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and ...

Tips for Hardware & Software Med Device Product Development

  Subscribe on any major podcast player. Today’s guest is Rob Crowder, Head of Product at Nutromics in Australia, which has a booming life science ...

What's the Best 21 CFR Part 11 Compliant Software in 2021?

There are plenty of software providers that deliver the functionality needed to help you become 21 CFR Part 11 compliant. You can meet the FDA’s ...

Premarket Notification 510(k) and Premarket Approval

 

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

  Subscribe on any major podcast player. Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated ...

Quality Assurance vs. Quality Control: What's the Difference?

Sound on! Listen to the audio version of this article (read by a real person) here: What is the difference between quality assurance (QA) and quality ...

4 PMA Application Methods for Medical Devices

Choosing the correct Premarket Approval (PMA) method can mean the difference between the success or failure of your growing medical device startup or ...

How to Ensure Your Quality Management System Processes and Procedures are Compliant in 2021?

In highly regulated industries like life sciences, you have to make sure every i is dotted, and every t is crossed. The US FDA and other regulatory ...

Fundraising Fundamentals with Greg Yap and JP Sanday from Menlo Ventures

  Subscribe on any major podcast player. Today’s guests are Greg Yap and Jean-Paul (JP) Sanday from Menlo Ventures where fundraising is the #1 ...

3 Important FDA Medical Device Guidance Documents to Bookmark

Are you struggling with medical device regulatory compliance? If so, you’re not alone. It’s an issue that thousands of growing medical device ...

Guest Post: Our Investment In Qualio: A New Breed of Quality Management System for Life Sciences

Author: JP Sanday, Partner, Menlo Ventures

How to Maintain a Quality Culture during Explosive Growth

  Subscribe on any major podcast player. Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in ...

Announcing Qualio's $50M Series B Funding Round

When I founded Qualio in 2012, I set out to create a platform that would enable companies to build with quality and speed. In the years since, it's ...

The Top 3 Pharmaceutical Venture Capital Firms

What are the best investment opportunities in the pharmaceutical industry this year? In response to COVID-19 and the rapid development of vaccines, ...

Succeeding in Quality Consulting with Lisa Helmonds, VP of Operations at MWA Consulting

  Subscribe on any major podcast player. Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which ...

EU Medical Device Training: 4 Amazing Programs

Today’s most successful organizations commit to continuous learning. It’s what separates industry-leading medical device and pharmaceutical startups ...

What is the ISO 13485 Quality Manual?

Did you know that medical devices are among the most highly regulated products? Some medical devices, including those within Class II and Class III ...

Expanding Med Device Distribution Internationally and in China

Subscribe on any major podcast player. Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company ...

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

In recent years, the biopharmaceutical industry has experienced an onslaught of regulatory changes.  When you consider the total volume of regulatory ...

What is the FDA 21 CFR? Requirements Overview

What is the best way to ensure that your medical device complies with all applicable laws and regulations?  Title 21 of the Code of Federal ...

4 Major Class II Medical Device Requirements

Many growing startups and scale-ups deal with non-compliance issues at one point or another.  Unfortunately, failure to meet major medical device ...

How to Prepare for and Pass an Audit – and What to Do Next

Sooner or later, every life sciences, biotech, pharma, or medical device manufacturer will face an audit. Whether that’s a pre-approval inspection, a ...

How to Build a Document Control Procedures Manual

How does your life sciences startup or scale-up manage its documentation? Unfortunately, ineffective document management can result in serious ...

Empowering Women With Personal Fertility Knowledge

  Subscribe on any major podcast player. Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to ...

Reviewing the 5 Best Document Management Systems for Life Sciences Companies

What are the best document management systems for life sciences companies?  For most growing startups and scale-ups, document management is a ...

The Best 21 CFR 7 Checklist for Medical Device Startups

If you had to issue a product recall tomorrow, would you be ready? According to the U.S. Food and Drug Administration (FDA), a recall removes and ...

Defining Quality: The Role, Responsibilities, and Industry

  Subscribe on any major podcast player. Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into ...

5 Amazing Medical Device Document Management Tips

What are the best medical device document management tips to help you improve organization and document procurement?  Most growing startups know that ...

Bringing New Tech to Developing Countries and Playing Pro Basketball

  Subscribe on any major podcast player. Today we welcome Mr. Assaf Barnea to the show. He is a former pro basketball player in Europe and currently ...

FDA Launches New Biocompatibility Assessment Resource Center

Are you trying to gauge the biocompatibility of your medical device for an upcoming audit or regulatory submission? 

5 Quality Control Procedures for Life Sciences Startups

In recent years, there has been an increased focus on merging product innovation with product safety and quality. Without an intimate understanding ...

How to Master Pharmaceutical QA in 4 Simple Steps

What does it take to master pharmaceutical quality assurance (QA)? The most successful pharmaceutical startups know that QA refers to anything that ...

4 Major Quality Requirements for Pharmaceutical Companies

What major laws or regulations does my pharmaceutical organization need to follow? As an industry-leading quality management system (QMS) provider, ...

The 5 Most Important Quality Equipment for Life Sciences Startups

What does it take to succeed as a life sciences startup? It’s a bit of a loaded question. Unfortunately, there isn’t a silver bullet to create ...

Customer Panel: Preparing for and Passing an Audit With Qualio

For life sciences organizations, preparing for and passing internal and external audits are required yet daunting tasks. While there is no one way to ...

Curing Incurable Diseases with Jeff Galvin from American Gene Technologies

  Subscribe on any major podcast player. What if incurable diseases like HIV, cancer, PKU, and epithelial solid tumors were completely curable? We're ...

How to Build the Best Quality Assurance Plan for Distributed Medical Manufacturers

What does it take to deliver maximum quality assurance? The most effective medical device manufacturers commit to quality-driven processes and ...

Qualio Ranks #1 in QMS Usability, Implementation, and Satisfaction on G2

Qualio has achieved the #1 spot in QMS implementation, usability, and momentum based on the responses of real users for each of G2's 2021 Spring ...

Is Your Client Ready for the EU MDR Deadline?

COVID-19 introduced some amendments to the European Union Medical Device Regulation (MDR) application date. As such, applicants have until May 26, ...

Combating COVID-19 with the Open Source Volunteers Extended Project

When the coronavirus pandemic began surging in February 2020, volunteers around the world sprang into action to do whatever they could to help. 

Solving the Four Most-Common Quality Management Issues

Solving quality management issues keeps your life sciences organization on the right side of the FDA. However, compliance isn’t the only benefit. ...

How to Get Non-Dilutive Funding via Federal Agencies

  Subscribe on any major podcast player. Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part ...

Awakening Millions with Brain-Controlled Interfaces with Andreas Forsland, CEO of Cognixion

  Subscribe on any major podcast player. Imagine if Stephen Hawking couldn't communicate. The world's understanding of theoretical physics would be ...

The Best Pharmaceutical Quality Assurance Courses Online

Keeping your team educated and motivated to make quality assurance a priority can lead to lasting quality improvements. Continuing learning can be ...

What Is cGMP In The Pharmaceutical Industry? An Expert Roundup

Understanding Current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can, at first, seem like trying to pick up a handful of ...

What Is A Document Control System and Why Does it Matter?

Last year, the FDA released 476 warning letters. The total included 201 letters about violation of current good manufacturing practices (cGMP) such ...

How to Maintain and Improve Quality Management While Working Remotely

  Subscribe on any major podcast player. Today on the podcast we're introducing a new type of episode: Quality Quick Tips.  Periodically we'll focus ...

Cirris Replaces Paper-Based Systems with Digital QMS

After nearly nine years of working as an engineering test specialist for broadcast television, Gene Vought joined Cirris — a manufacturing company ...

Quality Management Fundamentals in Aerospace and Life Sciences

  Subscribe on any major podcast player. Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, ...

Building and Scaling Venture-Backed Startups as a Female Founder with Jen Baird

Suffice it to say that venture capitalists aren’t necessarily known for generously funding female-led startups, but Jen Baird is the exception to ...

The 12 Essentials of Quality Management in Laboratory Environments

Sound on! Listen to the audio version of this article (ready by a real person) here:  The good news? Laboratory error rates have been on the decline ...

Improving Patient Safety at The Point of Care

  Subscribe on any major podcast player. Did you know about $6 billion is spent each year in medical device recall management? Having a product ...

Funding and Scaling your Med Device Startup with Jen Baird

  Subscribe on any major podcast player. Getting funding and scaling a medical device business alone is challenging. But challenges don't deter ...

CureMetrix Helps Radiologists Make Better, Faster Decisions With AI

It’s no secret the pandemic kept many people at home for the bulk of the last year.

Reducing Patient and Nurse Injuries with Charleen Solomon of AriseQ2

  Subscribe on any major podcast player. Did you know nurses are required to turn and change bed-bound patients every two hours? The primary reason ...

Qualio is Officially ISO 9001 Certified!

At Qualio, we’re all about helping life sciences, biotech, pharma, and medical device companies get products to market faster with our robust ...

Using Qualio for ISO 9001 Audit and Certification

ISO 9001 is an international standard that sets out the criteria for a quality management system. Organizations of all sizes and in all industries ...

Lessons from Building an Open Source Quality Community with Gill Berry

  Subscribe on any major podcast player. Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded ...

Using AI to Improve Healthcare Outcomes and Access with Sam Dribin

  Subscribe on any major podcast player. Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support ...

3 Major Regulatory Requirements for SaMD Companies

What are the major regulatory requirements for software as a medical device (SaMD) companies?  Without an intimate understanding of these ...

5 Major CAPA Medical Device Requirements

The corrective and preventive action (CAPA) quality processes consist of the critical activities life sciences organizations must activate to ...

Unlocking funding with IP and the inspiring story behind HAI Solutions

  Subscribe on any major podcast player. The story behind HAI Solutions is so inspiring and similar to many life science entrepreneurs who start ...

5 Amazing Life Sciences Companies to Watch in 2021

It only takes one groundbreaking startup to change a product category forever. This year, to prepare for the future and remain relevant in an ...

5 Fastest Growing Biotech Startups to Watch in 2021

How can you ensure your life science startup succeeds? Start by modeling your growth path after those that have come before you and gotten the ...

Spearheading the Life Science Industry with Claire Bonaci of Microsoft

  Subscribe on any major podcast player. Listen to this chat between Qualio CEO, Robert Fenton and Claire Bonaci from Microsoft about how the life ...

5 Key Elements of the ISO 13485 Standard

What are the key elements of the ISO 13485 standard? To obtain a CE marking—which indicates conformity with safety standards for products sold in the ...

Global Opportunities from Starting a Med Device Company in a Pandemic

  Subscribe on all major podcast players: Our guest today is Meow-Ludo. He’s an emerging technology evangelist and Chief Scientific Officer at Moth ...

5 Essential Elements of Quality Management Software

The world's most broadly adopted standard, ISO 9001:2015, includes a series of quality principles that are frequently referenced in other QMS ...

Improving Healthcare Access for Vulnerable Populations

2020 has been an unprecedented year. In times like these, mission-driven companies should challenge themselves to stay focused on their immediate ...

Linical Uses Qualio to Streamline CRO Efforts

Linical is a global contract research organization (CRO) that provides expertise to pharmaceutical and biotech companies to help them bring drug ...

5 Key Elements of the ISO 9001 Standard

Are you preparing for ISO 9001 certification? If so, it's important to remember that ISO 9001 nonconformance impacts thousands of life sciences ...

From Hippie to Med School to Entrepreneur with Dr. Hana, MD

  Subscribe on all major podcast players: If you have a nose, you should check out this episode. Dr. Hana Solomon, MD shares her journey from hippie ...

First Module of EUDAMED on Actor Registration Open

The European Commission has launched registration for the first module of the future European Medical Device Database. MDR EUDAMED is the first IT ...

5 Industry-Leading eQMS Vendors of 2021

Finding the right eQMS vendor for your growing life sciences organization is easier said than done. With so many different solutions out there, it ...

5 FDA Audit Preparation Tips for Life Science Startups

Are you preparing for an FDA audit? If so, there's a lot that can go wrong if your organization fails to take the time to adequately prepare. ...

4x Cancer Survivor to CEO/Founder. Patient-led Innovation

  Subscribe on all major podcast players: What if the next time you went to the receive healthcare at a clinic or hospital, you came out with an idea ...

The 5 Best Medtech Startups to Watch in 2021

Earlier this year, a record $5.5 billion in venture capital went to medtech companies. As global biotech companies continue to innovate and bring ...

Insights from Biotech Investor and Pioneer Ron Shigeta

  Ron Shigeta is a serial entrepreneur & startup biotech pioneer. He’s also been a serial founder having run startups in AI drug tox detection ...

5 Fundamentals of the CAPA Quality Process

The CAPA (corrective and preventative actions) quality system consists of the specific improvements an organization makes to its processes to ...

5 Amazing Startup Pharmaceutical Companies to Watch in 2021

Growing a pharmaceutical startup is hard work. But it can get slightly easier when you model your growth path after the pharmaceutical companies that ...

6 Things to Look for in a QMS Software for the Pharmaceutical Industry

The pharmaceutical industry is evolving, and firms must adopt more sophisticated processes and products to compete. Organizations are struggling to ...

The Best ISO 13485 Audit Checklists on the Web

An ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails. The standard includes 77 clauses, so there are a ...

Does an FDA Class 1 Medical Device List Exist?

Understanding where your product falls in FDA classifications can help medical device manufacturers plan for regulatory compliance. If you can find a ...

The 5 Noticeable Benefits of Implementing A QMS in 2021

Implementing a Quality Management System (QMS) can offer noticeable benefits to your entire organization. Some of these benefits can be measured ...

IRISYS Uses Qualio to Help Biotech & Pharma Firms Secure FDA Approval

IRISYS is a contract development and manufacturing organization (CDMO) headquartered in San Diego that helps biotech and pharmaceutical firms ...

Alphazyme Uses Qualio to Produce Molecular Enzymes

Alphazyme is a biotechnology manufacturer headquartered in Jupiter, Florida that produces custom enzymes that are used by large-scale biotech ...

The Difference Between ISO 13485 and ISO 9001 for Medical Devices

What's the difference between ISO 13485 and ISO 9001? Do we need to adhere to both or just one of them? Fortunately, you only need to worry about ISO ...

5 Objectives of Quality Assurance in the Pharmaceutical Industry

Imagine facing a Class 2 recall after your product ships! In 2010, Johnson and Johnson found itself battling a firestorm after the FDA recommended a ...

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

Are you having difficulty validating a quality management system (QMS)? As you know, validation provides a level of confidence in the software's ...

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software. This standard is ...

5 of the Best Options for Nonconformance Management Software

An investment in nonconformance management software can make or break your company. Choose the right software, and you can streamline and master your ...

The ISO 13485 Checklist for Medical Device Manufacturers

Are you preparing for ISO 13485 certification? If so, the process can be overwhelming. Keep reading to learn more about how to make the experience ...

How Much Does an ISO 9001 Quality Management System Cost?

Are you searching for an ISO 9001 quality management system but worried about overspending? If you choose a platform that's too costly and doesn't ...

Top 10 ISO 9001 Quality Management System Requirements

ISO 9001 certification can be a total game-changer for your business. So, what is ISO 9001? ISO 9001 standards are designed to help life science ...

5 FDA Pre-Submission Tips for Medical Device Manufacturers

You've just designed the greatest medical device of all-time. Now what? If you've developed a medical device similar to one that's already available ...

Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a ...

Understanding Risk Classification of Medical Devices: 3 Major Grades

Did you know that classifying your medical device incorrectly could extend the Food and Drug Administration's (FDA) approval process by months? As ...

5 Medical Device Supplier Innovations in 2020

Medical device suppliers have unveiled some amazing innovations this year. Failing to keep tabs on these advancements could keep you from growing ...

A Complete Overview of the FDA 510(k) Process (And How to Shorten It)

Did you know that the FDA rejects more than 75% of 510(k) applicants? Unfortunately, even the slightest delay or setback could spell disaster for ...

CGX Uses Qualio to Deliver Innovative EEG Headsets to Medical Researchers

CGX is one of the world’s leading manufacturers of dry electrode EEG headsets that are designed for researchers in the fields of simulation training ...

What to Look for in Quality Management Consulting Services

Do you how much your company spends on the cost of poor quality (CoPQ)? The average highly regulated organization spends 5-30% of gross sales on ...

4 Medical Device Manufacturers Revolutionizing Life Sciences in 2020

This year, medical device manufacturers are rising to the COVID-19 challenge by developing innovative new products. For example, industry leaders ...

What is eQMS Software Validation?

Before we dive into the specifics of electronic quality management system (eQMS) software validation, let's take a step back and briefly discuss why ...

Review of the Top FDA Software Validation Requirements

The FDA released its current guidance on General Principles of Software Validation in 2002. But a lot has changed since then. Which begs the ...

Top 7 Biotech Investors Changing the Life Science Industry

Is your biotech company looking for funding? If so, you need to find a biotech investor that understands your unique business and industry. ...

5 Essential Elements of a QMS for Medical Devices

Are you planning on investing in a Quality Management System (eQMS) for your medical device company? Without careful consideration and planning, a ...

The 3 Top Quality Assurance Conferences of 2020

In the last few months, the FDA has announced a few major changes designed to position the organization as a true leader in regulatory health ...

Review of the 5 Best Life Science Venture Capital Firms

A record $5.5 billion in venture capital went to biotech companies in Q1 2020. However, in light of the COVID-19 pandemic, experts indicate that ...

5 Steps to Securing Life Science Venture Capital

For most early-stage startups, securing venture capital is the most important first step towards sustained success. You see, venture capital can give ...

4 FDA Medical Device Reporting Procedures for Life Science Companies

As you know, medical device reporting procedures can be confusing. The laws are always changing, and your life science company needs to keep up with ...

5 Secrets to Securing Medical Device Venture Capital

As a founder of a medical device development company, securing medical device venture capital is one of the biggest barriers you will need to ...

What's the Difference Between a Class I and Class II Medical Device?

Does your medical device fall under the Class I or Class II category? Depending on where you manufacture and sell your products, you'll need to ...

An ISO 13485 Risk Management Plan Example You Can Steal and Use

When it comes to getting regulatory approval, creativity is rarely, if ever, a good thing. Medical device organizations have the opportunity to ...

Qualio Secures Series A Funding

March 12, 2020 was the day the Dow Jones Industrial Average had its largest drop since 1987, the year I was born. It was an important date during the ...

A Printable 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step

For life sciences companies, 21 CFR Part 11 compliance has always been a challenge. It requires irrefutable evidence that your organization is ...

How to Get a Quality Management Certification in 5 Simple Steps

Does getting a quality management certification keep you up at night? There's a lot at stake. Invest in the wrong certification and you might end up ...

5 Essential Tasks to Include in Your EU MDR Checklist

Is your life science organization working toward EU Medical Device Regulation (MDR) readiness? If you are a manufacturer, authorized representative, ...

The 5 Best ISO 14971 Training Programs

Are you up to date on the latest ISO 14971 developments? ISO 14971 is the application of a risk management process for medical devices. The third ...

5 Steps of a Quality Management Plan for Distributed Life Sciences Companies

If quality management is lacking within your distributed life sciences company, the success of your organization is in jeopardy. Without a quality ...

5 Online Medical Device Design Control Templates

Errors in design control can cause major issues for medical device companies. In fact, according to recent reports, the leading causes of product ...

10 Impressive Medical Device Startups to Watch in 2021

Is disruption on the horizon in your medical device category? It only takes one ground-breaking MedTech startup to change a product category forever. ...

The 5 Best Pharmaceutical Quality Systems Changing Life Sciences in 2020

This year, industry-leading pharmaceutical companies will make significant investments in quality management systems. An effective quality management ...

The Top Medical Device Trends in 2020

Is your life sciences company primed for growth? By adopting the latest medical device trends, your organization can achieve significant growth, ...

FDA Regulatory Compliance Software: Cloud vs. On-Premises

Should you use a cloud-based FDA regulatory compliance software or host a solution on-premises? It's a question we hear a lot. Many companies ...

5 Pharmaceutical Manufacturing and Quality Management Trends

Recently, studies have predicted that the value of the pharmaceutical industry will increase to $1.5 trillion by 2023. In anticipation of this ...

The 4 Phases of Clinical Trials (And How to Guarantee Quality Assurance During Every Step)

Getting ready for FDA clinical trials can be an intimidating and overwhelming process—especially if this is your first time going through it. Since ...

Qualio Named Top Performer in the Spring 2020 Quality Management Software Customer Success Report

Qualio has been named a Top Performer in the Quality Management Software category for the Spring Customer Success Report published by ...

The 8 Essential Functions Of CAPA Management Software

CAPA causes more compliance trouble for life sciences companies than any other area of quality management. Year after year, it's the number one ...

Single Sign-On With SAML2 Now Available for Qualio

While Qualio already has solid user permissions and digital signatures, some companies prefer to use the access control already in use by their ...

How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps

Without a solid ISO 14971 risk assessment methodology in place, defining risk can sometimes be like answering the question, "How big is big?" ...

How to Build an FDA Audit Strategy During the COVID-19 Pandemic

The COVID-19 Pandemic is causing businesses everywhere to have to make changes to the way they operate. While some industries are more impacted than ...

The Medical Device Startup Process: Avoid These 7 Deadly Missteps

Did you know that seven new startups will launch in the time that it takes you to read this blog post? Unfortunately, four of those startups will ...

EU Medical Device Regulation: Is Your eQMS Helping or Hurting?

Adjusting to regulatory changes like the new EU Medical Device Regulation can be difficult at every level. But is your eQMS making it even harder ...

5 Tips to Get ISO 13485 / ISO 14971 Certification

Is your medical device company spending too much time trying to comply with regulatory requirements? If so, you're not alone; it's a problem that ...

International Medical Device Regulations vs FDA 21 CFR: 4 Crucial Differences

Maintaining international regulatory standards is a real challenge, even for the most astute medical device organizations. Recently, the FDA issued a ...

Quality Management Initiative for Coronavirus and COVID-19

Quality Management Initiative for coronavirus and COVID-19 Starting today, we are offering our cloud Quality Management System (QMS) software and ...

6 Best Practices from Six Sigma that Medical Device Companies Should Follow

Let me tell you the secret to turning your medical device company into the market leader in your category: You have to build a quality-driven ...

7 Medical Device Conferences to Get You Ready for EU MDR

Are you worried that some obscure clause in the new EU MDR standard will trip your company up? Is the push to meet the deadline stressing your team ...

Design Controls for a Medical Device: 5 Secrets for Success

As you know, designing a new medical device can be exhilarating. However, if you get caught up in the excitement and fail to properly document your ...

7 ISO 13485:2016 Changes That Can Make Your Company Better

Has your medical device company lost its competitive edge? If you’re struggling to comply with quality standards, it may be time to go back to the ...

The 5 Best Medical Device Product Lifecycle Management Tools

Picking the right medical device product life cycle management (PLM) tool is a huge deal. Selecting the wrong PLM could lead to headaches and legal ...

The 6 Best US Pharmaceutical Conferences to Attend in 2020

Bored. Behind-the-times. Unmotivated. Those are not words you want used to describe your team. One of the best ways to make sure you get to and ...

Qualio Named Quality Management Leader in G2 Winter 2020 Report

Among the eight quality management solution providers in G2's Winter 2020 Momentum Report, Qualio has received the highest Momentum Score based on ...

14 Medical Device Quality Management System Requirements for Regulatory Compliance

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...

Medical Device Consultant Rates for 2020: What You Should Get for Your Investment

The medtech industry is in a constant state of flux. Medical device consultant rates are also subject to change, like everything else in the ...

Medical Device Quality Assurance and Regulatory Compliance in 2020: What You Should Know

Maintaining an edge means staying ahead of the competition and regulatory bodies when it comes to medical device quality assurance and regulatory ...

The 6 Best Medical Device Consulting Services: What They Offer

Is your medical device company facing an uphill battle with the FDA? Are you struggling to pass an audit and get ISO-certified quickly? The best ...

Reviewing the Best Medical Device Risk Management Consultant Options for 2020

Uncertainty breeds anxiety. And medical device manufacturers have plenty of reasons to be anxious. The current device risk climate has caused ...

Finding the Best Pharmaceutical Regulatory Consulting Services for Your Organization

Does the thought of an FDA audit, warning, or recall make you nervous? The cost of non-compliance with current good manufacturing practices (cGMP) is ...

Medical Device Quality Management System Template: 5 Powerful Options

A great quality management system (QMS) can give you what you need to get a high-quality device on the market quickly and obtain FDA approval and ISO ...

Quality Management Software for Medical Devices: The 8 Essential Requirements

You already know that your current quality management system is hurting your medical device company — but how do you pick the right replacement? Your ...

Reviewing the Top Medical Device Quality Software Options for 2020

Times are changing and it’s getting harder and harder to keep up with ever-changing regulations using a paper-based quality management system. If ...

7 Signs You Need Pharmaceutical Quality Assurance Consulting

Is your pharmaceutical company making headlines? Most businesses can survive a quality glitch or two (or even three), but when “Big Pharma” messes ...

Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring

The FDA will send out three 483 observation letters today — will one of them be going to you? The process you have to go through to bring a medical ...

The 6 Top Medical Device Consulting Firms You Should Short List for 2020

Which are the top medical device consulting firms in 2020? That's a big question because the right consultant for your organization can speed up your ...

Quality Management Services: The 4 Essential Qualifications to Look For

Do you want to know what holds most young life sciences companies back from rapid growth? It's the false idea that you only have two options when ...

Life Sciences Quality Management System: 5 Must-Have Features & Functionality

The right life sciences quality management system (QMS) can put your organization in a position to get to market quickly, scale fast, breeze through ...

How Much Does Medical Device Regulatory Consulting Cost in 2020?

How much do medical device regulatory consulting firms charge? That's the first question to ask when trying to answer the bigger question, "Are they ...
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