Medical Device Quality, Regulatory and Product Development Blog

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

By Nick Tippmann on January 16, 2019

Do you know the difference between quality management system (QMS) and quality systems management (Q...

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

By Stephanie Christopher, MA, Program Director, Case for Quality & Science of Patient Input on January 13, 2019

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...

Aligning True Quality and Compliance with MDDAP

By Nick Tippmann on January 9, 2019

What does true quality mean? How does it relate to compliance?

Why Contract Manufacturers Shouldn't Own Your Quality System

By Jon Speer on January 7, 2019

Does your medical device company use a third-party or contract manufacturer?

Explaining the Significance of Voluntary Consensus Standards

By Nick Tippmann on January 2, 2019

What are Voluntary Consensus Standards? Why should you care about them? What role do they play in yo...

FDA Case for Quality: 2018 Comprehensive Review

By Jon Speer on January 1, 2019

Top 10 Most Popular Greenlight Guru Posts of 2018 - Featured Image

Medical Device Industry Predictions for 2019

By Nick Tippmann on December 19, 2018

It’s time to recap what happened in the medical device industry this year and start to think about w...

Defining Your Medical Device Design Records

By Jon Speer on December 18, 2018

It’s easy to get a bit confused when you consider the records that are required for your medical dev...

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

By Jon Speer on December 9, 2018

Within the past couple of years, we have experienced significant changes in the medical device indus...

FDA Plans to Modernize 510(k) - Is the Sky Falling?

By Nick Tippmann on December 5, 2018

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

By ECM (Ente Certificazione Macchine) on December 5, 2018

In less than four months, come March 2019, the transitional period for medical device companies to c...

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