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

What Devicemakers Need to Know About Medical Device Reporting (MDR)

By Nick Tippmann on January 25, 2017

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

By Jon Speer on January 9, 2017

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...

Top 10 Most Popular Medical Device Articles of 2016 (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

By Nick Tippmann on September 12, 2016

Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational.

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016

A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

By David Amor on June 16, 2016

MedTech startups thrive on lean-ness. Part of lean-ness is knowing how and when to scale regulatory ...

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

By Nick Tippmann on December 15, 2015

If you are in the business of medical devices, then you must eat, breathe, and live quality manageme...

20 Most Popular Medical Device Posts of 2015 from greenlight guru

By Nick Tippmann on December 14, 2015

2015 was a huge year for Greenlight Guru! A lot happened. From publically launching our product in F...

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

By Nick Tippmann on September 22, 2015

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken ...

Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?

By Jon Speer on September 10, 2015

I’d like to take a few minutes to share with you a story. One where a CEO of a medical device startu...

How To Reduce & Prevent Medical Device Complaints

By Jon Speer on November 13, 2014

Congratulations! You have successfully launched a new medical device after months and months of prod...

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