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Biotech
• April 13, 2026

The Readiness Paradox: Why Audit Success Does Not Guarantee Clinical‑Stage Readiness in Biotech

Introduction: The Confidence Gap In growth‑stage biotech, passing a GLP audit or pre‑IND inspection has long been treated as proof that the business ...
Biotech
• April 10, 2026

Your Compliance Model: Effective Now, Vulnerable Later

Let us start with something the rest of this content series has not said directly:
MedTech
• April 08, 2026

Audit-Ready vs Scale-Ready: Why Passing Is Not Proof

Most MedTech companies do not fail audits.
medical device Quality Management System (QMS)
• April 06, 2026

Continuous Readiness Is Becoming the New Operating Standard in MedTech

For decades, medical device organizations have managed Quality and Compliance as a series of events.
Medical Devices
• March 25, 2026

Mastering QMSR: Key Takeaways and Strategies
Compliance
• February 25, 2026

The structural limits of generic GRC in modern life sciences
Medical Devices
• February 20, 2026

Regulation isn't slowing your medical device. Fragmentation is.
Medical Devices
• February 18, 2026

If compliance is slowing you down, your regulations are not the problem. Your model is.
Medical Devices
• January 12, 2026

What is the FDA QMSR?
Pharmaceutical
• December 12, 2025

How AI is reshaping pharmacovigilance: key takeaways from the new CIOMS report
Compliance
• December 10, 2025

Top 10 conferences for life science companies in 2026
ISO 9001
• December 09, 2025

8 ways to fail an ISO audit in 2026

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 ...
Medical Devices
• December 09, 2025

25 impressive medical device startups to watch in 2026
eQMS
• December 08, 2025

5 secrets to securing medical device venture capital in 2026
Funding
• December 08, 2025

5 tips for pitching your life science company to investors in 2026
Quality management
• December 05, 2025

5 tips for planning your quality management budget in 2026
eQMS
• December 03, 2025

Introduction to quality control software
Quality management
• December 03, 2025

8 benefits of a quality management system (QMS) in 2026
Computerized System Assurance
• December 02, 2025

Complete guide to computer system validation in 2026
Pharmaceutical
• December 01, 2025

Pharmaceutical quality management software (QMS): our top picks for 2026
Document Control
• December 01, 2025

What to know about document control software in 2026
Pharmaceutical
• November 29, 2025

2026 guide to pharmaceutical software
Compliance
• November 20, 2025

Essential ISO software features for life science GRC

ISO software is an increasingly pertinent investment for life science companies juggling the complex governance, risk and compliance (GRC) ...
Medical Devices
• November 19, 2025

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 ...
Quality Systems
• November 19, 2025

Mastering quality management in laboratory environments: 12 essential techniques for 2026
Compliance
• November 13, 2025

Why pharmaceutical regulatory compliance software is essential for biopharma companies
Computerized System Assurance
• November 11, 2025

What do the FDA's CSA guidelines mean?
ISO 15189
• November 10, 2025

What is ISO 15189? A complete overview
Compliance
• November 06, 2025

What's the best regulatory compliance management software for life science companies?
eQMS
• November 04, 2025

What's the best eQMS software in 2026?
Medical Devices
• September 19, 2025

Your complete guide to the Medical Device Single Audit Program (MDSAP)
Compliance
• September 16, 2025

Announcing: Compliance Intelligence

If you’re building a life science company, you know the feeling: every new product you develop, every new market you plan to enter and every new ...
IVDR
• August 26, 2025

Ultimate guide to the EU IVDR: everything you need to know
Medical Devices
• July 17, 2025

Overview of ISO 14155

If you're performing or outsourcing clinical investigations of a medical device, ISO 14155 is the standard for you.
GxP
• July 02, 2025

All about GMP labeling: requirements and best practices
GxP
• July 02, 2025

Good Manufacturing Practices (GMP) explained

If you make a sensitive, regulated product, Good Manufacturing Practices, or GMP, are critical to your operation.
Pharmaceutical
• June 30, 2025

The complete guide to the ICH Q7 guidelines

What is ICH Q7, and how can it benefit your company? Safeguarding the quality of active pharmaceutical ingredients (APIs) is critical for assuring ...
eQMS
• June 12, 2025

Transforming design controls in our new Qualio upgrade
Medical Devices
• May 30, 2025

Ultimate guide to the IEC 62304 standard

Need help brushing up on your IEC 62304 standard knowledge?
Document Control
• May 08, 2025

What is EDMS software?
eQMS
• March 13, 2025

Kicking off 2025 with more integrations and deeper data connections for Qualio customers
ICH
• March 13, 2025

What is ICH E6 R3? Good clinical practice explained
ISO 9001
• March 13, 2025

The ultimate ISO 9001 overview: quality management systems
eQMS
• January 29, 2025

CureMetrix helps radiologists make better, faster decisions with AI
eQMS
• January 22, 2025

Kicking off 2025 with new G2 accolades from our customers
FDA
• January 14, 2025

The 3 FDA medical device classes: differences and examples explained
Quality management
• January 13, 2025

Quality assurance vs. quality control explained: 5 key differences
eQMS
• December 13, 2024

Qualio leaps to the front of the pack in integrated eQMS providers
eQMS
• December 04, 2024

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 ...
Medical Devices
• December 04, 2024

Understanding post-market surveillance for medical devices
Compliance
• October 29, 2024

What you should know about the CE mark
Compliance
• October 21, 2024

What you should know about UKCA marking

If your medical device business plans to introduce its product to the $25bn UK market, you'll need to incorporate UKCA marking into your quality and ...
Pharmaceutical
• October 17, 2024

The role of CAPA in pharma
eQMS
• September 24, 2024

Q-Pulse vs. Qualio: a comprehensive guide to eQMS for life science companies
eQMS
• September 23, 2024

Qualio named Top Compliance Software for 2024
Medical Devices
• September 18, 2024

ISO 13485: the essential guide
Quality management
• September 17, 2024

What is a quality management system (QMS)?
FDA
• September 17, 2024

5 things we learned at the PDA/FDA Joint Regulatory Conference 2024
eQMS
• September 03, 2024

Our biggest product upgrade yet: UX, AI and more!
Case Studies
• August 29, 2024

How to double your ISO 13485 certification speed with Qualio
Integrations
• August 20, 2024

Ultimate guide to Qualio integrations

Integrations aren't just about making your life easier and your work faster – though of course that's important.
Quality management
• July 18, 2024

What are the differences between quality management, quality control and quality assurance?
Compliance
• July 09, 2024

A guide to writing corrective and preventive action (CAPA) reports
Medical Devices
• July 09, 2024

What is design control for medical devices and how does it work?
eQMS
• July 05, 2024

Faster, streamlined quality processes powered by AI in Qualio
Quality management
• June 25, 2024

What is total quality management (TQM) and how does it differ from a QMS?
Quality management
• June 20, 2024

How to develop and implement a quality management system (QMS)
Compliance
• June 14, 2024

What is Corrective Action Preventive Action (CAPA)?
eQMS
• June 10, 2024

Advancing the Qualio Way by cutting the stress from change management and simplifying custom event visibility and tracking
Compliance
• June 03, 2024

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 ...
Compliance
• May 30, 2024

CDSCO registration: how to bring your medical device to India
Compliance
• May 29, 2024

The ultimate guide to change control for life sciences companies
SaMD
• May 20, 2024

The complete guide to SaMD (software as a medical device)
eQMS
• May 15, 2024

How to Manage the Med Device Software Development Process in Your eQMS

Managing the medical device software development process is a big undertaking. Software as a device is regulated like any other medical device, but ...
ISO 9001
• May 13, 2024

Navigating climate change: updates to ISO certification standards
Medical Devices
• May 08, 2024

What the FDA's 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 ...
Compliance
• May 08, 2024

The EU AI Act: what to expect
Medical Devices
• May 02, 2024

The top 10 life science quality assurance consultants to work with in 2024

Life sciences consulting, particularly quality assurance consulting, can offer a transformational kickstart for your life science company. Securing a ...
Medical Devices
• May 01, 2024

The 9 top medical device consulting firms you should consider for 2024

Which are the top medical device consulting firms your business should look at for your 2024 plans? The right consultant expertise can speed up your ...
Pharmaceutical
• May 01, 2024

The top 8 pharmaceutical consulting firms you should consider for 2024

Thinking of working with a pharmaceutical consulting firm in 2024? The right consultant team can slice your time to market, help you embed lasting ...
Quality management
• April 17, 2024

Life science quality management system: 5 must-have features

The right life sciences quality management system (QMS) can put your organization in a position to get to market quickly, scale fast, breeze through ...
Industry Awards
• April 02, 2024

Catalyst Awards 2024: the 17 most exciting life science start-ups and scale-ups to watch this year
ISO 17025
• March 22, 2024

How to get an ISO 17025 certification

ISO 17025 certification is the international quality benchmark for the modern testing and calibration laboratory.
eQMS
• March 21, 2024

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 ...
Medical Devices
• March 20, 2024

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 ...
Medical Devices
• March 20, 2024

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. ...
Quality-Driven
• March 18, 2024

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 ...
eQMS
• March 14, 2024

Reinventing eQMS document management (and more!) in our biggest product release yet
ISO 13485
• March 13, 2024

How to choose ISO 13485 QMS software in 2026
eQMS
• March 04, 2024

CAPA management software: benefits, top features, and how to select the best
Quality Systems
• January 05, 2024

How to solve the four most common quality management issues in 2024
Medical Devices
• January 05, 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, ...
Quality management
• January 05, 2024

What Are The 7 best online quality management training courses for 2024?
eQMS
• January 05, 2024

What are the 5 best options for nonconformance management software in 2024?
21 CFR Part 11
• January 05, 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 ...
Medical Devices
• January 05, 2024

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 ...
eQMS
• December 07, 2023

Making work even easier for our customers in our November Launch Train
Pharmaceutical
• December 01, 2023

Top pharma conferences in 2024
Quality Systems
• November 22, 2023

The ultimate guide to pharmaceutical quality assurance
Biotech
• November 08, 2023

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 ...
Pharmaceutical
• November 07, 2023

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 ...
Company news
• November 02, 2023

I'm Qualio's chief product officer. Here's what the future of our software looks like.
GxP
• November 01, 2023

Good distribution practice: understanding GDP compliance
ISO 9001
• October 16, 2023

How much does ISO 9001 certification cost?

For quality-focused organizations, ISO 9001 certification cost is a critical and unavoidable hurdle to overcome.
510(k)
• October 13, 2023

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

What is an FDA 510(k) submission - and how do we complete one?
Company news
• September 13, 2023

Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023
eQMS
• August 10, 2023

Fresh features and time-saving shortcuts in our latest product release
FDA
• August 09, 2023

PMA submissions: 4 PMA application methods for medical devices
FDA
• July 20, 2023

Guide to 21 CFR Part 11 compliance [free checklist]
FDA
• July 19, 2023

PMA meaning: understanding FDA pre-market approval
GxP
• July 11, 2023

What is GxP in pharma?
FDA
• July 03, 2023

21 CFR Part 820: the complete overview
ICH
• June 30, 2023

Guide to ICH E6 (R3): changes and preparation
Quality management
• June 26, 2023

The hidden costs of a free quality management system
Company news
• June 23, 2023

Summer of customer love: more Qualio accolades at the G2 Summer Awards
eQMS
• June 14, 2023

Powerful quality analytic insights in our latest product launch
Quality management
• June 09, 2023

What is quality assurance?
Medical Devices
• May 24, 2023

The TGA's essential principles explained
ICH
• May 17, 2023

What you need to know about ICH Q8
ICH
• May 15, 2023

ICH Q9 quality risk management: an introduction
Medical Devices
• May 10, 2023

The complete guide to passing ISO 13485 audits
Medical Devices
• April 26, 2023

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 ...
GxP
• April 26, 2023

What you need to know about FDA 21 CFR Part 211
GxP
• April 21, 2023

What you need to know about FDA 21 CFR Part 210
eQMS
• April 19, 2023

Faster access to your quality landscape with our latest product upgrades
Podcast
• April 18, 2023

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 ...
Company news
• April 14, 2023

Spring in our step at the G2 Spring Awards 2023
GxP
• April 14, 2023

Guide to GxP compliance: processes, challenges and tools
Pharmaceutical
• April 05, 2023

Top pharmaceutical companies: 5 start-ups to watch in 2024
Podcast
• April 05, 2023

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 ...
Pharmaceutical
• March 14, 2023

What is cGMP in the pharma industry? 7 experts explain
ICH
• March 07, 2023

What is an ICH Q10 pharmaceutical quality system?
Medical Devices
• February 24, 2023

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices
Compliance
• February 17, 2023

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 ...
510(k)
• January 30, 2023

510(k) submission checklist to get your medical device to market
Company news
• January 19, 2023

Qualio donates 1% of revenue to charity for a third consecutive year
• January 18, 2023

5 tips for quality management compliance
Document Control
• January 18, 2023

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 ...
Audit
• January 16, 2023

Understanding the MDSAP's nonconformity grading system
510(k)
• January 12, 2023

When to submit a 510(k) vs. a Premarket Approval
Medical Devices
• December 22, 2022

The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022
Podcast
• December 20, 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 ...
• December 15, 2022

2023 is nearly here. Time to reflect on another successful year!
Industry Awards
• December 14, 2022

Qualio smashes customer review records at G2 Winter 2023 Awards
Product Updates
• December 12, 2022

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)
• December 12, 2022

510(k) exempt medical devices: how to tell if you need to submit
Podcast
• December 09, 2022

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 ...
Pharmaceutical
• November 23, 2022

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 ...
Medical Devices
• November 18, 2022

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 ...
Product Updates
• November 08, 2022

The next wave of Qualio upgrades arrives
Compliance
• October 20, 2022

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 ...
Computerized System Assurance
• October 19, 2022

Qualio launches new validation approach
Industry Awards
• September 23, 2022

Qualio takes prizes at the G2 Fall Awards 2022
Compliance
• September 22, 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 ...
Medical Devices
• September 14, 2022

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 ...
Computerized System Assurance
• September 13, 2022

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 ...
Podcast
• September 09, 2022

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 ...
Medical Devices
• September 01, 2022

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 ...
Compliance
• August 30, 2022

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 ...
Medical Devices
• August 23, 2022

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 ...
Pharmaceutical
• August 16, 2022

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.
Compliance
• August 09, 2022

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 ...
GxP
• August 02, 2022

What is GxP in the life sciences industry?
• August 01, 2022

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 ...
Pharmaceutical
• July 28, 2022

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 ...
Medical Devices
• July 05, 2022

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 ...
Biotech
• June 30, 2022

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 ...
Medical Devices
• June 28, 2022

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 ...
Industry Awards
• June 27, 2022

Qualio maintains momentum at the G2 Summer Awards 2022
Start-Up
• June 17, 2022

The 5 best spots in the United States to start a life science company
Pharmaceutical
• June 16, 2022

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 ...
Medical Device Start-Up
• June 13, 2022

How to start a medical device company
Medical Devices
• June 09, 2022

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 ...
FDA
• May 27, 2022

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 ...
Integrations
• May 19, 2022

Qualio launches triple integration release
Medical Devices
• May 11, 2022

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). ...
Culture
• May 10, 2022

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 ...
Podcast
• May 06, 2022

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 ...
MHRA
• April 07, 2022

Tips for passing your MHRA inspection
Podcast
• April 06, 2022

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 ...
Podcast
• March 29, 2022

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 ...
Industry Awards
• March 23, 2022

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 ...
eQMS
• February 22, 2022

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 ...
eQMS
• February 03, 2022

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 ...
Medical Devices
• January 17, 2022

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 ...
Pharmaceutical
• January 12, 2022

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 ...
• December 22, 2021

Qualio as a Force for Good: Year 2 of Improving Healthcare Access for Vulnerable Populations
Quality Systems
• September 09, 2021

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 ...
Medical Devices
• August 31, 2021

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 ...
iso9001
• August 24, 2021

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 ...
Medical Devices
• August 19, 2021

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 ...
Medical Devices
• August 17, 2021

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 ...
eQMS
• August 12, 2021

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). ...
Medical Devices
• August 10, 2021

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 ...
Podcast
• August 05, 2021

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 ...
Medical Devices
• July 27, 2021

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 ...
eQMS
• July 22, 2021

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 ...
eQMS
• July 20, 2021

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 ...
Medical Devices
• July 15, 2021

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 ...
Pharmaceutical
• July 08, 2021

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 ...
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