Greenlight Guru Medical Device Blog

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Establishing a QMS

June 16, 2022

MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality

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Establishing a QMS

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

June 2, 2022

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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

June 11, 2021

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Product Development

The Medical Device Practical Guide to PMCF Requirements under EU MDR

Jon Bergsteinsson

October 3, 2022

The European Medical Device Regulation (EU MDR) deadlines are closing in for re-certification and/or introduction of new products. Read More

Product Development

3 Tips For Incorporating Risk Management During Medical Device Product Development

September 30, 2022

Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these... Read More

Regulatory Submission

9 Questions About the European MDR Answered

September 29, 2022

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the... Read More

Product Development

10 Tips for Selecting the Right EDC Software for Clinical Investigations

Páll Jóhannesson

September 29, 2022

Using Electronic Data Capture (EDC) software can save you time and money in the data collection process for your medical device clinical investigation - but how do you... Read More

Product Development

7 Common 510(k) Mistakes and How to Avoid Them

Etienne Nichols

September 28, 2022

The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of... Read More

Product Development

Medical Device Classification Guide - How To Determine Your Device Class

September 28, 2022

What I am about to share with you is a guide to medical device regulatory classification. Read More

Establishing a QMS

Four Years, For You

September 27, 2022

Celebrating Four Years as the Leading QMS, as Selected by Users Read More

Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

September 25, 2022

A medical device is only as good as its parts. Read More

Product Development

IEC 82304 vs IEC 62304: Software Standards for SaMD Explained

Etienne Nichols

September 23, 2022

IEC 82304-1 is one of many standards that medical device companies should use while developing software as a medical device (SaMD). It covers the requirements for... Read More

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