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Jon Speer

Jon Speer
Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Author's Posts

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria - Featured Image

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...
Why Flexible Design Reviews Matter for Medical Device Product Development - Featured Image

Why Flexible Design Reviews Matter for Medical Device Product Development

It is my humble and expert opinion that the medical device industry has the most significant impact ...
What to Expect During an FDA QSIT Inspection - Featured Image

What to Expect During an FDA QSIT Inspection

You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...
5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...
Introducing The Greenlight Guru True Quality Roadshow 2019 - Featured Image

Introducing The Greenlight Guru True Quality Roadshow 2019

To the Medical Device Community, From the moment Greenlight Guru was founded, we have taken our lead...
Best Practices for Effective Medical Device Design Reviews - Featured Image

Best Practices for Effective Medical Device Design Reviews

Design Reviews are intended to be checkpoints during medical device product development to ensure th...
Why Contract Manufacturers Shouldn't Own Your Quality System - Featured Image

Why Contract Manufacturers Shouldn't Own Your Quality System

Does your medical device company use a third-party or contract manufacturer?
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

Defining Your Medical Device Design Records - Featured Image

Defining Your Medical Device Design Records

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) - Featured Image

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

Within the past couple of years, we have experienced significant changes in the medical device indus...
FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing - Featured Image

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...

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