Medical Device Quality, Regulatory and Product Development Blog

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

By Etienne Nichols on October 10, 2021

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?

By Tom Rish on October 8, 2021

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)?

By Sara Adams on October 7, 2021

Quality management is an essential part of manufacturing any product, regardless of size, complexity...

When to Throw the Least Burdensome Flag on FDA

By Nick Tippmann on October 6, 2021

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?

By Sara Adams on October 5, 2021

When it comes to medical devices, compliance isn’t based on the honor system.

Creating a Quality Manual That Complies with ISO 13485

By Taylor Brown on October 3, 2021

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

By Nick Tippmann on September 28, 2021

“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

By Jon Speer on September 26, 2021

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

By Nick Tippmann on September 24, 2021

“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

By Nick Tippmann on September 23, 2021

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

By Nick Tippmann on September 22, 2021

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?

By Ryan Behringer on September 21, 2021

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

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