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

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

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

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
Greenlight Guru Named Premier QMS Software for NIH RADx Initiative - Featured Image

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.
Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

Medical device labeling requirements are a key part of getting your device to market.
How to Use the FDA ESG (Electronic Submissions Gateway) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and proce...
Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS - Featured Image

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...
How to Demonstrate Substantial Equivalence in 5 Easy Steps - Featured Image

How to Demonstrate Substantial Equivalence in 5 Easy Steps

If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equiv...
How to Use Voluntary Consensus Standards to your Strategic Advantage - Featured Image

How to Use Voluntary Consensus Standards to your Strategic Advantage

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...
How does EU MDR impact your Quality Management System? - Featured Image

How does EU MDR impact your Quality Management System?

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device? - Featured Image

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...
Virtual Auditing in a Post-COVID World of Digital Compliance - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...

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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