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Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

What I am about to share with you is a guide to medical device regulatory classification.
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

Change is constant… Especially in the medical device industry. Medical device change management can ...
Top 40+ Medical Device Conferences To Attend in 2020 - Featured Image

Top 40+ Medical Device Conferences To Attend in 2020

Simply attending the right medical device conference can be a game-changer for those who work in the...
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
3 Pros and Cons to 3D Printing for Medical Devices - Featured Image

3 Pros and Cons to 3D Printing for Medical Devices

3D printing processes — which use digital models to create physical devices out of materials like pl...
5 Myths about QA/RA Recruiting in the Medical Device Industry - Featured Image

5 Myths about QA/RA Recruiting in the Medical Device Industry

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device ...
How to Solve the Medtech Value Equation with Quality Data - Featured Image

How to Solve the Medtech Value Equation with Quality Data

Which medical technology, product, or device are you actively focused on bringing to market that wil...
Why Supplier Quality Management Is So Important - Featured Image

Why Supplier Quality Management Is So Important

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...
State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...
FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Preparing for EU MDR - Featured Image

Preparing for EU MDR

Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...
Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

Does your company develop electrical medical devices? The standard IEC 60601 is different from other...

The Greenlight Guru Medical Device Blog

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

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