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What's the best eQMS software in 2023? [Top 5 options]

An electronic quality management system (eQMS) doesn’t just make life easier for quality teams. As the life science world gets increasingly ...

What the FDA's new MDDS guidance means for you

  The medical device world, like almost every other industry on Earth, gets more digitized by the day. So it's no surprise to see industry bodies ...

Everything you need to know about the FDA 510(k) submission

  What is an FDA 510(k) submission - and how do we complete one?

The 5 best pharmaceutical consultants to work with in 2023

  Thinking of hiring an experienced pharmaceutical consultant in 2023? The right expert can lift your business to the next level, helping you embed ...

8 best ISO 13485 training programs in 2023

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

The top 6 pharmaceutical consulting firms you should consider for 2023

  Thinking of working with a pharmaceutical consulting firm in 2023? We've assembled a list of the top 6 you should consider. The right consultant ...

From Emergency Medicine to Disrupting EHR Technology with Dr. Brian Fengler, Co-founder of EvidenceCare

    Dr. Brian Fengler joins us on the show to talk about the latest in healthtech and innovating EHR technology to save lives in fewer clicks. Brian ...

The 4 best ISO 13485 audit checklists

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 ...

Everything you need to know about ISO 13485

Have you spent countless stressful hours preparing for ISO 13485 certification? You’re not alone. ISO 13485 is the internationally recognized quality ...

Engineering quality in organizations to better meet patient needs with Matt Wictome from Datod Consulting

    We've know many who have or had the job title of "Quality Engineer" however many outside the industry may not consider "quality engineers" to ...

How Dogs Can Be Used in Research and Science with Kayla Fratt Co-Founder of K9 Conservationists

    We’re going to deviate from our typical life sciences for just a few moments just for fun to talk about dogs. We’ve heard about dogs using their ...

The next wave of Qualio upgrades arrives

 

The FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The United State Federal Drug Administration (FDA) plans to present a draft revision of its Quality System Regulation— FDA 21 CFR 820—that brings it ...

How to get to market faster with medical device outsourcing with Jeff Barrett, CEO of J-Pac Medical

    We're excited to dive into the world of full-service medical outsourcing with Jeff Barrett, President and CEO OF J-Pac Medical. Jeff Barrett has ...

A step-by-step guide to internal quality audits

Gearing up for a quality audit is no small feat. Whether it’s your organization’s first time being audited or the 100th, there’s always room for ...

Qualio launches new validation approach

 

Using Advanced AI to Curate Individualized Cancer Treatments with Navid Alipour, CEO of AI Med Global

    Today, we are chatting with Navid Alipour. Navid is the founder and CEO of AI Med Global. Navid believes that with consistent advancements in the ...

How to manage nonconformances in medical devices

It's important for medical device manufacturers to have a clear understanding of nonconformances—often referred to as NCs—and how to properly manage ...

9 core elements of a quality management system [Examples]

Every life science company knows that quality is of the utmost importance. But defining quality and aligning that definition to regulations requires ...

The ultimate guide to change control for life sciences companies

For any organization that makes a product, it's important to have change controls in place, but what are change controls? How do they differ from ...

Complete guide to computer system validation in 2022

 

Testing a Gene Therapy to Cure HIV & Fundamentally Change Healthcare with Jeff Galvin of American Gene Technologies®

    Today, we are excited to chat with Jeff Galvin, CEO of American Gene Technologies®. We are so glad to have Jeff back on the show, we first spoke ...

Qualio takes prizes at the G2 Fall Awards 2022

 

Helping Medical Device Companies Accelerate Launches to Market with CiteMed's Ethan Drower

    Today, we are chatting with Ethan Drower, co-founder and operating partner of CiteMed, which is revolutionizing the European Union Medical Device ...

What are the types of quality audits?

Audits. If you work in life sciences, you know that quality audits are a part of creating life changing products. Though all quality audits aim to ...

What do the FDA's new CSA guidelines mean?

 

Understanding post-market surveillance for medical devices

After spending years developing and testing your medical device, getting it to market is an exciting achievement. But your job isn't done yet. Once ...

What is a bill of materials? A guide for medical devices

When you first embark on building a new piece of furniture, you’re usually holding a small booklet that outlines every part inside your box. Lining ...

Product and Software Development for MedTech Solutions with Piotr Zajac, CEO of Untitled Kingdom

    What does the future of med tech look like? Piotr Zajac of Untitled Kingdom is tackling just that with his team and company. As they say, ...

The 10 key changes in the GAMP 5 Second Edition

  The GAMP 5 Second Edition, the newest version of the ISPE's computerized system guidance, was released in July 2022, replacing the First Edition ...

Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn

    Ever wondered about your genes and overall health?  In today's episode, we will talk about just that with Dr. J Dunn. We go over wholistic ...

Everything you need to know about Design History Files (DHF)

One of the most important things a medical device company can do to help bring products to market quickly is to stay organized. If your team isn't ...

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11 applies to any official quality or manufacturing records pertaining to the design, development, or manufacture of a drug or device ...

What you need to know about medical device validation

When medical devices work properly, they keep us healthy, moving, monitored, and—in some cases—alive. They're a growing sector in the healthcare ...

Marketing must-knows for healthcare companies with Webtek Interactive

    Are you a life sciences start-up founder and want to bring your business to market, but don't know how? Marketing is something that is ...

How to start a pharmaceutical company

Starting your own business takes time, energy, and money—and if you're building a pharmaceutical startup, there’s even more to consider.

8 impressive medical device startups to watch [2022]

As history has shown, it only takes one ground-breaking MedTech startup to change a product category forever.

21 CFR Part 11: A guide for clinical trial compliance

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The ...

What is GxP in the life sciences industry?

In the 1990s, the drug fen-phen soared in popularity as many people used it to help with weight loss. However, the drug began to cause heart valve ...

What is an electronic batch record?

According to a report from the Food and Drug Administration (FDA), more than 400 organizations receive a letter for not complying with standard ...

The pros & cons of pharmaceutical contract manufacturing

Manufacturing a new drug is an expensive process, especially for startups with limited resources. That’s why many biopharmaceutical and ...

A complete guide to 21 CFR Part 11 for medical device manufacturers

Listen to the audio version of this article read by a real person here (Sound on!): Making sure that medical devices meet the required quality ...

How to choose CAPA software: 8 essential functions

Listen to the audio version of this article read by a real person here (Sound on!): In the life sciences industry, regulators require that companies ...

Home testing for everyone, everywhere with Paul Chapman of Domus Diagnostics

    We all experienced the importance of at-home testing from the Covid19 pandemic and today's guest is helping bring rapid, affordable, and accurate ...

Medical device quality management system template: 8 powerful options

Starting a medical device company is an immense task. You have plans to make, employees to hire, funding to obtain, and on top of all that, you have ...

Building a Digital Health Startup with Shuo Qiao of Moving Analytics

    Today on the show we're joined by Shuo Qiao, Co-founder and Chief Technology Officer of Moving Analytics. We discuss his career path and how it ...

6 biotech incubators for startups in the U.S.

The cost of getting a biotech startup off the ground is high. Founders not only need to find the right partners, but they must also consistently ...

Saving Lives and Early Cancer Detection with David Suhy of Earli

    Can a chemical found in citrus fruit curb cancer and save lives through early detection? Today on the show, we'll talk about the possibilities ...

A comprehensive guide to ISO 14971: Risk management for medical devices

This is a guide for medical device professionals looking to gain a deeper understanding of the risk management process and how it may be applied. A ...

Qualio maintains momentum at the G2 Summer Awards 2022

 

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? Listen to the audio version of this article read by a real person here (Sound ...

Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo

    Today we’re catching up with Dr. Heather Underwood, CEO of EvoEndo. EvoEndo recently completed an $8.4 million Series A financing round on the ...

The 5 best spots in the United States to start a life science company

 

Biotech vs pharma: Differences and similarities

To laypeople, the words “biotech” and “pharma” might seem interchangeable. But when you understand the difference between biotech vs. pharma, you can ...

Entrepreneurship and Representation in Healthcare Technology with Gulé Sheikh

    Today we speak with developer turned health-tech founder Gulé Sheikh. We discuss her innovations and entrepreneurship at a leading tele-health ...

The 12 essentials of quality management in laboratory environments

Most people will experience at least one diagnostic error in their lives—including errors in lab tests in medical laboratories. A tiny error can lead ...

How to start a medical device company

 

A practical guide to implementing Risk Management for medical device startups

Risk Management continues to be a hot topic in the medical device world as regulators place additional emphasis on the role of risk management ...

The Benefits of Helmet-Based Ventilation with Aurika Savickaite

    Non-invasive ventilation (NIV) is a life-saving tool used throughout ICUs to manage respiratory failure. The traditional form of non-invasive ...

How Artificial Intelligence Can Accelerate Drug Discovery and Bridge the Translational Gap with Jo Varshney of VeriSIM Life

    The average cost of developing a new drug is estimated at over $2 billion. Roughly 10% of pre-clinical drugs ever make it to human trials. And ...

5 tips for pitching your life science company to investors

 

5 ways to make the FDA audit process easier for your life sciences company

Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the ...

Rebuilding Biopharma & Personalized Precision Medicine with Diego Rey Cofounder of Endpoint Health and YC Grad

    What if you started a company like Roche (est. in 1896) from the ground up? How would you approach drug development differently given enabling ...

The EU IVDR: everything you need to know (Ultimate Guide)

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, better known as the EU IVDR, goes live today!

Qualio launches triple integration release

 

Catalyzing Chemical Reactions & Scientific Collaboration with Nobel Laureate David MacMillan

    What’s the background of a Nobel Prize winner in chemistry, where are the next innovations in science, and how do you say “asymmetric ...

How SaMD companies can use a QMS to improve regulatory compliance

Nearly a decade ago, the International Medical Device Regulators Forum (IMDRF) released its guidelines for Software as a Medical Device (SaMD). ...

Qualio: officially Best Place To Work!

  I'm really pleased to announce that Qualio has made the list of Inc. Magazine's Best Workplaces of 2022 with an overall employee satisfaction score ...

The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies

    Today, we have Lyn Yaffe joining us. Lyn is the Co-founder, Chairman, and CEO of EPR-Technologies. EPR Technologies is a biomedical spinoff of ...

Accelerating Medtech's time to market with a modern regulatory strategy with James Gianoutsos, Founder of Rimsys

    Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations (EU MDR) and In Vitro Diagnostic ...

Outsourcing to a contract organization? You still need an eQMS. Here's why.

  I recently attended the American Biomanufacturing Summit in San Francisco. It sure was nice to be back in person! The company booth was lovely and, ...

A guide to writing Corrective and Preventive Action (CAPA) reports

Listen to the audio version of this article read by a real person here (Sound on!): It’s stressful to receive an observation or warning letter from ...

Software as a medical device: Definition, examples, and regulatory trends

Software has “eaten” many industries ever since investor Marc Andreessen penned his famous column ten years ago. And the healthcare industry is no ...

Modernizing the EUMDR Clinical Evaluation Report Process with Ethan Drower Co-founder of CiteMed

    Adopting EU MDR is either going to make or break some regulatory teams. With some major updates to EU MDR in the past couple years, the need for ...

Using AI & Virtual Patients to Make Clinical Trials Safe, Affordable, and Scalable with François-Henri Boissel CEO of Novadiscovery

    One of the primary issue plaguing R&D for new drugs is the experimental discovery (trial & error) process. Success rate is very low and ...

Tips for passing your MHRA inspection

 

Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility

    Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to talk about her journey as a ...

How to build a quality culture in startups. Panel discussion with 5 quality experts.

    To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from ...

Empowering parents & caregivers to identify toxic stress in children with Bryon Bhagwandin CEO of Recalibrate Solutions

    Stress is part of life but a dysregulated stress system should not be. Unfortunately, many children experience stress so frequently that it ...

Everything You Need to Know About Design Controls for Medical Devices

Navigating the medical device regulatory environment can seem daunting at times, and it's easy to get lost in the technical jargon of the standards. ...

Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio

    It's not hard to find someone who has been affected by diabetes and the rising cost of insulin. In fact, today's guest says that 1 in 10 people ...

Overcoming barriers in infrastructure and human capital with Joseph Mocanu PhD from Verge Healthtech Fund

    You may have heard the adage, "an ounce of prevention is worth a pound of cure." Today's guest Joseph Mocanu, PhD shares how companies and ...

Improving Healthcare Access for Vulnerable Populations in 2021

    This past year—much like the year before—has put increasing pressure on professionals working in life sciences and healthcare. We hear the ...

Creating “future proof” antibodies vs. virus variants like Omicron with Ian Chan, co-founder of Abpro

    Today's guest is Ian Chan the co-founder and executive chairman of Abpro. Abpro is improving the lives of mankind facing severe and ...

Harnessing Digital Talent to Solve Crises with Courtney Brown from WHO & The Millennial Group

    About Courtney: Courtney Brown started her career within Australia’s first digital banking proposition, ING Direct. She is dynamic and ...

Remote auditing: tips for the future

The pandemic may have made remote audits a necessity, but there’s no reason they shouldn’t be here to stay. 

Qualio starts 2022 the right way at the G2 Spring Awards

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 ...

Eulogy for Q. Emmess

Today, as Qualio publishes our 2022 life science quality trends report which reveals that almost half of quality professionals have already digitized ...

Restoring Hearing Loss with Novel Therapeutics with Laurence Reid CEO of Decibel Tx

  Did you know that hearing loss is one of the largest areas of unmet need in medicine? It affects approximately 466 million people worldwide, ...

Rethinking Your Market Access Strategy with Dinesh Kabaleeswaran, Sr. Dir. of Insights and Advisory at MMIT

  Today's episode we explore the ins and outs of market access strategy with Dinesh Kabaleeswaran,  Sr. Dir. of Insights and Advisory at MMIT. Learn ...

Quality Assurance vs. Quality Control Explained: 5 key differences

Listen to the audio version of this article about  5 key differences of Quality Assurance vs. Quality Control  read by a real person here (Sound ...

Tips for moving from a paper-based QMS to an eQMS

Paper-based quality management systems have been a mainstay for life sciences organizations. A paper-based approach can be easy to stand up within an ...

European Market Strategy, Acquisitions and Disrupting the Drug Discovery Value Chain with Tanja Dowe from Debiopharm Innovation Fund

  We're excited to have, from all the way in Switzerland, Tanja Dowe the CEO of Debiopharm Innovation Fund on the show. Tanja has a background in ...

Busting myths about eQMS vendors

“Are you guys certified to ISO 13485? How about ISO 14971? The IVDR transition period is about to end and the industry is scrambling, do you guys ...

Changing the Game for Drug Delivery with Robert Niichel, CEO of SmartTab

  Robert Niichel the CEO of SmartTab is creating ingestible capsules for drug delivery of biologics and targeted medications. Think of a pill you ...

3 thoughts about quality software integrations

Integrations.

The quality manager's guide to rapid eQMS success: validation, adoption and implementation

Electronic quality management systems (eQMS) were generally limited in their infancy to costly, custom on-premise platforms developed specifically ...

Meet the Qualio customer success team

Our customer success team are a friendly bunch. They're here to make Qualio customers happy and successful quality professionals with complete ...

How a quality assurance director freed up a week each month for continuous improvement using Qualio

New York-based Koneksa provides digital biomarker technologies for the remote capture of clinical trial data.

The FDA's approach to digital health technology (DHT) is changing. That's a big deal.

In December 2021, the FDA revealed its draft guidance on "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations".

The 4 Best Medical Device Quality Assurance Training Options

Listen to the audio version of this article read by a real person here (Sound on!): Organizations spend $12 billion a year on quality assurance, ...

What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]

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.

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

Listen to the audio version of this article read by a real person here (Sound on!): It can be a challenge to maintain a company-wide dedication to ...

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 ...

The 3 FDA Medical Device Classes [Differences and Examples Explained]

There are three distinct FDA Medical Classes. If you're getting a replacement heart valve, you want to know the device going in your chest went ...

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 ...

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 ...

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 ...

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)? [Definition and Components]

Read below if you would like more information regarding Device History Records and its different components. What is the best way to ensure that your ...

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. Listen to the audio version of this article read by a real person here (Sound on!): Almost ...

What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?

Listen to the audio version of this article read by a real person here (Sound on!): If you've never completed a medical device clinical evaluation ...

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? [Timeline]

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? Listen to the ...

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 software in 2022?

  There are multiple 21 CFR Part 11 software providers that can help you meet the requirements of the FDA's electronic record regulations.  But a ...

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 ...

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 2022

In a highly regulated industry like life science, you have to make sure every 'i' is dotted and every 't' is crossed. The 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? Listen to the audio version of this article read by a real ...

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 ...

What Are the 5 Best Document Management Systems [Review] 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? Listen to the audio version of this article read by a real person ...

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. 

How to Solve the Four Most-Common Quality Management Issues? (2022)

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 ...

What Are The Best Pharmaceutical Quality Assurance Courses [Online]?

Pharmaceutical quality assurance courses play an important part in keeping your team educated and motivated to make qu|Yality assurance a priority ...

What Is cGMP In The Pharma Industry? We Interview 7 Industry Experts!

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

How A Document Control System Can Transform Your Business?[7 Benefits]

Listen to the audio version of this article read by a real person here (Sound on!): Last year, the FDA released 476 warning letters including 201 ...

How to maintain and improve quality management while working remotely

 

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 ...

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 ...

How to pass an ISO 9001 audit with Qualio

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

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 ...
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