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Tips for Success When It Comes to IEC 60601 with Leo Eisner - Featured Image

Tips for Success When It Comes to IEC 60601 with Leo Eisner

  IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise t...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

What role do you believe design controls play in the growth and stability of your company? I suspect...
How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources - Featured Image

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...
Medical Device Risk – ISO 14971 Gets It Right - Featured Image

Medical Device Risk – ISO 14971 Gets It Right

Editor's note: This is a guest post authored by William Storage, VP LiveSky Inc., Visiting Scholar, ...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

What happens you need to make a change to a device that’s been cleared via 510(k)?
An Introduction to FDA 21 CFR Part 11 - Featured Image

An Introduction to FDA 21 CFR Part 11

Every week that goes by, I talk to several medical device companies all over the world who have esta...
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two) - Featured Image

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

FDA Pre-submissions: They're a hot, timely topic.
Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations - Featured Image

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Di...
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...
Tips for Avoiding Problems with the First-In-Human Study Process - Featured Image

Tips for Avoiding Problems with the First-In-Human Study Process

When it comes to moving from the conceptual phase of developing a medical device and actually doing ...
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...
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose - Featured Image

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

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

The greenlight.guru Medical Device Blog

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