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Catalyst Awards 2024: the 17 most exciting life science start-ups and scale-ups to watch this year

How to get an ISO 17025 certification

ISO 17025 certification is the international quality benchmark for the modern testing and calibration laboratory.

Everything you need to know about ISO 13485

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 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 ...

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. ...

What to look for in quality management consulting services in 2024

Looking for more information about making the right decision around quality management consultant? Do you how much your company spends on the cost of ...

Reinventing eQMS document management (and more!) in our biggest product release yet

What's the best eQMS software in 2024?

How to choose ISO 13485 QMS Software in 2024

For medical device companies looking for quality management system (QMS) software in 2024, evaluating solutions based on ISO 13485 can offer numerous ...

25 impressive medical device startups to watch in 2024

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

How to choose CAPA software in 2024

What to know about document control software in 2024

The best document management software for life sciences [reviews]

Starting 2024 with more G2 success

Top 10 conferences for life science companies in 2024

How to solve the four most common quality management issues in 2024

Pharmaceutical quality management software (QMS): our top picks for 2024

8 best ISO 13485 training programs in 2024

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

What Are The 7 best online quality management training courses for 2024?

What are the 5 best options for nonconformance management software in 2024?

A comprehensive review of the best 21 CFR Part 11 software in 2024

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 ...

How Much Is the FDA Medical Device Registration Fee in 2024?

For its fiscal year of 2024, stretching from October 1 2023 through September 30 2024, the Food and Drug Administration (FDA) medical device ...

QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The United State Federal Drug Administration (FDA) recently presented its Quality Management System Regulation or QMSR, harmonizing FDA 21 CFR 820 ...

Making work even easier for our customers in our November Launch Train

Top pharma conferences in 2024

The ultimate guide to pharmaceutical quality assurance

5 tips for planning your quality management budget in 2024

6 strategies for successful biotech funding

The biotech industry is booming. After a slight dip in the days of COVID, funding in biotech has ultimately skyrocketed. A McKinsey article found ...

Understanding the major pharmaceutical regulations you need to know

Pharmaceuticals offer a critical, often life-saving capability to patients across the globe. For that reason, pharmaceutical regulations are an ...

I'm Qualio's chief product officer. Here's what the future of our software looks like.

Good distribution practice: understanding GDP compliance

8 ways to fail an ISO audit in 2024

A common word of encouragement you'll hear from colleagues when they find out that you're facing an ISO audit: "Good luck!" Of course, luck isn't a ...

How much does ISO 9001 certification cost?

For quality-focused organizations, ISO 9001 certification cost is a critical and unavoidable hurdle to overcome.

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

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

2024 guide to pharmaceutical software

5 things we learned at the PDA/FDA Joint Regulatory Conference 2023

Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023

Fresh features and time-saving shortcuts in our latest product release

PMA submissions: 4 PMA application methods for medical devices

Guide to 21 CFR Part 11 compliance [free checklist]

PMA meaning: understanding FDA pre-market approval

What is GxP in pharma?

The ultimate ISO 9001 overview: quality management systems

21 CFR Part 820: the complete overview

Guide to ICH E6 (R3): changes and preparation

The hidden costs of a free quality management system

Summer of customer love: more Qualio accolades at the G2 Summer Awards

What is ICH E6 R2? Good clinical practice explained

What is ISO 15189? A complete overview

Powerful quality analytic insights in our latest product launch

What is quality assurance?

5 fundamentals of the CAPA quality process

The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects ...

The TGA's essential principles explained

What you need to know about ICH Q8

ICH Q9 quality risk management: an introduction

The complete guide to passing ISO 13485 audits

Top 6 conferences in Australia for life science companies in 2023

As Australia emerges as a vibrant, expanding market for the life science industry, we've turned our eyes towards some of the key industry events ...

What you need to know about FDA 21 CFR Part 211

What you need to know about FDA 21 CFR Part 210

Faster access to your quality landscape with our latest product upgrades

Ernie Wallerstein, Jr., CEO of Mental Health Technologies

How can technology be used to treat - and even model and predict - mental health? Ernie Wallerstein, CEO of Mental Health Technologies, thinks he has ...

Spring in our step at the G2 Spring Awards 2023

Guide to GxP compliance: processes, challenges and tools

Top pharmaceutical companies: 5 start-ups to watch in 2024

Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient

Lifesaving drugs only work 50% of the time. The reason? Broad-stroke treatments that gloss over the individual variations in our bodies. For Dr. Mo ...

Mastering quality management in laboratory environments: 12 essential techniques for 2024

What is cGMP in the pharma industry? 7 experts explain

What is an ICH Q10 pharmaceutical quality system?

5 secrets to securing medical device venture capital in 2023

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? You’re certainly not alone. Compliance pressures in pharma have never been ...

The 7 best medical device consultants to work with in 2023

Hiring an experienced medical device consultant in 2023 can streamline even your most complicated go-to-market projects and help you jump challenging ...

What is a quality management system (QMS)?

510(k) submission checklist to get your medical device to market

The 3 FDA medical device classes: differences and examples explained

Complete guide to computer system validation in 2024

Qualio donates 1% of revenue to charity for a third consecutive year

5 tips for quality management compliance

We just launched the best native document editor on the eQMS market

If documents are the lifeblood of your quality management system, then easy and logical document creation is the beating heart. Other eQMS platforms ...

Complete guide to the MDSAP's nonconformity grading system

When to submit a 510(k) vs. a Premarket Approval

5 benefits of a quality management system (QMS) in 2024

Implementing a quality management system (QMS) can offer noticeable benefits to your entire organization. Recognizing and communicating these ...

The top 7 medical device consulting firms you should consider for 2023

Which are the top medical device consulting firms your business should look at as we approach 2023? The right consultant expertise can speed up your ...

The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022

Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health

The future of healthcare depends on fast, targeted and effective treatment. And for that, rapid diagnostics are indispensable. We invited Mehdi ...

2023 is nearly here. Time to reflect on another successful year!

Qualio smashes customer review records at G2 Winter 2023 Awards

Even faster and easier training with Training Plans

Keeping your colleagues up-to-date with role-specific training is vital for any life science business. And for Qualio customers, keeping up with your ...

510(k) exempt medical devices: how to tell if you need to submit

Modernizing the Lab with Nathan Clark Cofounder of Ganymede

What does a modern life science lab look like? How much manual data processing will take place? Hopefully very little if Ganymede continues to make ...

How to build a complaint management system

What’s more dreadful than receiving a customer complaint? Being asked by a regulatory auditor how you handled the complaint and if you effectively ...

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 like ...

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 ...

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 team ...

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 ...

The next wave of Qualio upgrades arrives

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

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 ...

Qualio takes prizes at the G2 Fall Awards 2022

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 ...

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 kinesiology ...

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 ...

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.

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?

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

Making sure that medical devices meet the required quality standards is essential to protecting public safety. In order to ensure compliance, medical ...

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 ...

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 ...

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

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 ...

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 ...

5 tips for pitching your life science company to investors in 2024

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 ...

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

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 the ...

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

It’s stressful to receive an observation or warning letter from the Food and Drug Administration for corrective and preventive action (CAPA) ...

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 ...

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 scientist ...

Everything you need to know about design controls for medical devices

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 in ...

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 ...

Quality Assurance vs. Quality Control Explained: 5 key differences

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 ...

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 ...

The 4 Best Medical Device Quality Assurance Training Options

Organizations spend $12 billion a year on quality assurance, which seems like a lot until you learn they lose twice that amount on issues related to ...

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

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

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

Ultimate guide to Qualio integrations

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

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 ...

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 ...

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 ...

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 ...

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 start-up 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'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. ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 quality assurance a priority can ...

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

Last year, the FDA released 476 warning letters including 201 letters about violation of current good manufacturing practices (cGMP) such as document ...

How to maintain and improve quality management while working remotely

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 ...

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 ...

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 ...

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 to ...

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 ...

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer and consumer. Imagine ...

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 ...

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 ...

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 ...

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 ...

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 ...

What Are The Top FDA Software Validation Requirements? [Review]

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in ...

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. Listen to ...

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 ...

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 ...

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 ...

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, ...
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