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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 170,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Laura Maher
November 13, 2022

Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Jesseca Lyons
October 4, 2022
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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Product Development

Design Assurance: The Unsung Heroes of R&D

Etienne Nichols
October 13, 2022
What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition,... Read More
Product Development

Guidance on How to Conduct Clinical Investigations Under EU MDR

Jon Bergsteinsson
October 13, 2022
The Questions and Answers guidance document from the European Commission's Medical Device Coordination Group (MDCG) provides answers to some of the outstanding questions for... Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

Jon Speer
October 10, 2022
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

Jon Speer
October 10, 2022
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Product Development

MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU

Laura Court
October 9, 2022
MDCG 2020-5 is a guidance document put out by the European Commission (EC) to clarify the process for demonstrating equivalence with another CE marked medical device.  Read More
Product Development

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

Jesseca Lyons
October 7, 2022
The medical device industry has a lot of acronyms.  Read More
Product Development

Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?

Tom Rish
October 7, 2022
On September 12th, 2022, FDA issued its latest draft guidance, which offers new recommendations for computer software assurance.  Read More
Product Development

Lessons from an Industry Leader: Playing the Long Game of MedTech

Etienne Nichols
October 6, 2022
What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway?... Read More
Product Development

Generate MDR Compliant Clinical Data with Investigator-Initiated Studies

Jon Bergsteinsson
October 6, 2022
The number of Investigator-Initiated Studies (IIS’s) conducted globally is on the rise. Independent patient-focused clinical studies led by physicians play an integral role... Read More

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