All articles by Kelly Stanton

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 ...

9 Best ISO 13485:2016 Training Programs in 2021

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

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 ...

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). ...

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, ...

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's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

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

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 ...

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 ...

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

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