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3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
Creating a Quality Manual That Complies with ISO 13485 - Featured Image

Creating a Quality Manual That Complies with ISO 13485

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...
Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile - Featured Image

Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical d...
How to Execute a Successful Product Launch - Featured Image

How to Execute a Successful Product Launch

Bringing a medical device to market can take anywhere from three to seven years, on average. The des...
Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical - Featured Image

Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

“Having partners with common values is just as important as the product or services themselves.” Dan...
3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US - Featured Image

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

Anyone who works in the medical device industry will tell you that quality and patient care is of th...
Top 3 Reasons for FDA 483 Observations in 2020 - Featured Image

Top 3 Reasons for FDA 483 Observations in 2020

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...
3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers - Featured Image

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...
5 Biggest Quality Mistakes (And How You Can Avoid Making Them) - Featured Image

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...
5 Postmarket Surveillance System Musts for Every EU Manufacturer - Featured Image

5 Postmarket Surveillance System Musts for Every EU Manufacturer

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...
3 Things Med Device Startups Must Do When Implementing a QMS - Featured Image

3 Things Med Device Startups Must Do When Implementing a QMS

I often hear early-stage medical device companies say they’re not ready for a quality management sys...
First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform - Featured Image

First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform

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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