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

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

By Nick Tippmann on March 26, 2020

In this modern digital world, did you know that most medical devices are not connected to the Intern...

How to Leverage IEC 62304 to improve SaMD Development Processes

By Nick Tippmann on March 18, 2020

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

By Nick Tippmann on March 12, 2020

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

By Taylor Brown on February 9, 2020

As leaders of medical device companies, our goal is always to create devices that are safe and effec...

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

By Nick Tippmann on January 29, 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...

4 Major Reasons to Use Document Version Control Software for your Medical Device

By Taylor Brown on January 26, 2020

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...

7 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on January 15, 2020

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...

Medical Device Classification Guide - How To Determine Your Device Class

By Tom Rish on January 2, 2020

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

By Nick Tippmann on December 28, 2019

Change is constant… Especially in the medical device industry. Medical device change management can ...

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

By Nick Tippmann on December 18, 2019

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...

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