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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...
What is a Class 1 Medical Device? - Featured Image

What is a Class 1 Medical Device?

In the US, the governing body tasked with regulating the medical device market is the Food and Drug ...
What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)? - Featured Image

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

Quality management is an essential part of manufacturing any product, regardless of size, complexity...
When to Throw the Least Burdensome Flag on FDA - Featured Image

When to Throw the Least Burdensome Flag on FDA

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional infor...
What is an ISO Audit? - Featured Image

What is an ISO Audit?

When it comes to medical devices, compliance isn’t based on the honor system.
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...
Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis - Featured Image

Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis

Fast-growing software company to host grand opening event to celebrate company’s investment in growt...
Past, Present, Future State (and World) of Quality in the Medical Device Industry - Featured Image

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Quality is a concept that is often overcomplicated in the medical device industry. With complexity c...
How Should Artificial Intelligence in Medical Devices be Regulated? - Featured Image

How Should Artificial Intelligence in Medical Devices be Regulated?

Take a close look at any global industry and you’ll find them all locked in the same race toward inn...

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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