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Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

By Nick Tippmann on June 23, 2021
A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

By Etienne Nichols on June 18, 2021
The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

By Nick Tippmann on June 14, 2021
What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

By Jon Speer on June 11, 2021
Examining the HHS Proposal for Premarket Notification Exemptions - Featured Image

Examining the HHS Proposal for Premarket Notification Exemptions

By Nick Tippmann on June 7, 2021
What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...
FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

By Jon Speer on May 28, 2021
Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Regulatory Tips & Pointers from a Former FDA Reviewer - Featured Image

Regulatory Tips & Pointers from a Former FDA Reviewer

By Nick Tippmann on May 17, 2021
As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamle...
Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) - Featured Image

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

By Nick Tippmann on May 12, 2021
Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...
Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program - Featured Image

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

By Nick Tippmann on May 11, 2021
What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program...
4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

By Wade Schroeder on May 7, 2021
The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? - Featured Image

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

By Nick Tippmann on May 6, 2021
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps - Featured Image

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

By Jesseca Lyons on April 25, 2021
The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...

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