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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 over 18+ years industry experience. Jon knows bringing a device to market is hard, so he built greenlight.guru to make it easier.

Author's Posts

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes

The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
What's with the Rush to First-In-Human Studies? - Featured Image

What's with the Rush to First-In-Human Studies?

Any medical device initially starts with an idea — a problem to solve, with the hope of positively i...
Why Poor Design Controls Mean More Medical Device Complaints - Featured Image

Why Poor Design Controls Mean More Medical Device Complaints

I’ll venture a guess that you want to get your medical device to market ASAP!
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
8 Reasons Why Your Design Controls And Risk Management Processes Fail - Featured Image

8 Reasons Why Your Design Controls And Risk Management Processes Fail

Design controls and risk management processes should be tools for medtech professionals to ensure th...
7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included) - Featured Image

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

Attention: If you are a medical device company and you have class II or class III products registere...
4 Medical Device Quality System Musts for Startups - Featured Image

4 Medical Device Quality System Musts for Startups

Medical device startups have a pile of things to address yet often don’t have the pile of money to t...
Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015 - Featured Image

Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015

When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happenin...
Debunking 4 Commonly Held Design Control Myths - Featured Image

Debunking 4 Commonly Held Design Control Myths

The design control struggle is real. What is the struggle, you ask? Design controls are not being us...
3 Tips for Managing Your Medical Device Design History File - Featured Image

3 Tips for Managing Your Medical Device Design History File

Developing a cutting edge medical device can be really fun and exciting. There’s always something to...

The greenlight.guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.