Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Software as a Medical Device: Definitions, Examples & Regulatory Framework

By Wade Schroeder on October 14, 2021

Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...

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 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...

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...

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...

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...

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...

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...

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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