Medical Device Quality, Regulatory and Product Development Blog

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...

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

By Tom Rish on September 19, 2021

Anyone who works in the medical device industry will tell you that quality and patient care is of th...

Debunking 4 Commonly Held Design Control Myths

By Jon Speer on September 17, 2021

The design control struggle is real.What is the struggle, you ask? Design controls are not being use...

True Quality: Greenlight Guru consistently ranked the #1 QMS by users for three years in a row

By Nick Tippmann on September 16, 2021

Greenlight Guru is proud to announce that for three years straight, we have been named the leader in...

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

By Nick Tippmann on September 15, 2021

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...

What is the FDA Medical Device Registration Process?

By Laura Court on September 14, 2021

To patients and providers, medical devices are more than a product. They serve as the conduit to bet...

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

By Jon Speer on September 13, 2021

So you need to make a change to your medical device, what now?

Top 3 Reasons for FDA 483 Observations in 2020

By Etienne Nichols on September 12, 2021

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...

How to Use the MDSAP Companion Document

By Taylor Brown on September 10, 2021

When people speak of bringing a medical device “to market,” the location of that market is often lef...

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