Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019

As a medical device professional, you are well aware of how much time and effort goes into getting y...

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...

How General Wellness Devices Have Opened a Pandora's Box of Confusion

By Nick Tippmann on July 31, 2019

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor ...

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

By Nick Tippmann on July 24, 2019

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including ...

Importance of Software Requirements in Product Development

By Nick Tippmann on July 17, 2019

Software and other requirements are critically important to medical device product development.

4 Facts That May Surprise You About FDA

By Nick Tippmann on July 10, 2019

From creating product codes to following regulations, do you ever wonder what goes on inside the U.S...

8 Most Common Mistakes to Avoid with 21 CFR Part 820

By Jon Speer on June 23, 2019

Medical device companies selling or planning to sell into the US market should be familiar with FDA'...

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on June 17, 2019

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As ...

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

By Jon Speer on March 17, 2019

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...

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...

FDA Case for Quality: 2018 Comprehensive Review

By Jon Speer on January 1, 2019

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