Medical Device Quality, Regulatory and Product Development Blog

What You Need to Know About the FDA CDRH Experimental Learning Program

By Nick Tippmann on September 19, 2018

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...

The Importance of Good Document Management (And How To Do It)

By Jon Speer on September 16, 2018

The long-term success of medical device companies depends on the strength of their foundation. Good ...

Why the FDA Case for Quality Matters

By Jon Speer on September 13, 2018

When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn mo...

15 HABITS OF HIGH EFFECTIVE QUALITY AND REGULATORY PROFESSIONALS

By Nick Tippmann on September 12, 2018

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...

21 CFR Part 11: A Complete Guide

By Jon Speer on September 10, 2018

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...

Greenlight Guru Announces Advanced Document Management

By Nick Tippmann on September 5, 2018

Functionality enhances security while maintaining visibility and transparency in medical device qual...

How to Embrace Risk for Safer Devices

By Nick Tippmann on September 5, 2018

No matter what you are working on, there are risks involved. Product development is complicated.

Scaling Regulatory and Quality with Your Company

By Jon Speer on September 2, 2018

Have you thought about your systems and processes related to regulatory and quality standards?

What you need to know About FDA’s Progressive Programs

By Nick Tippmann on August 29, 2018

Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Exp...

FDA Case for Quality Program: What, Why and How?

By Jon Speer on August 26, 2018

We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program. Th...

What are the regulatory expectations for software as a medical device (SaMD)?

By Nick Tippmann on August 22, 2018

These days, medical devices often include software or are standalone software. So, software as a med...

AI Explainability: What That Means and Why it Matters in Healthcare

By Jon Speer on August 19, 2018

Is AI a topic we should be focused on in the medical device industry?

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