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

Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information

By PA Consulting on May 6, 2021

We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our ...

Managing Business Risk as a Medical Device Company

By Nick Tippmann on May 3, 2021

It's easy to get so wrapped up in the risk management of your medical device that you forget about m...

Waterfall vs. Agile: Battle of the Product Development Methodologies

By Nick Tippmann on April 28, 2021

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?

For the Love of Internal Auditing

By Nick Tippmann on April 26, 2021

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me...

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

By Nick Tippmann on April 21, 2021

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...

5 Steps to Faster-to-Market, More Profitable Medical Devices

By PA Consulting on April 20, 2021

Healthcare provider market demands are such that medical device companies often find themselves in s...

Knowing vs. Doing as Medical Device Professionals

By Nick Tippmann on April 19, 2021

For medical device professionals, there are the “knowers” and the “doers.”

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

By Nick Tippmann on April 15, 2021

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.

Pivoting Operations to Meet PPE Demand during Pandemic

By Nick Tippmann on April 14, 2021

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...

Pros & Cons of Being a Physician turned MedTech Inventor

By Nick Tippmann on April 13, 2021

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...

What is a Quality Agreement for Medical Devices?

By Taylor Brown on April 11, 2021

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

Understanding the Investigational Device Exemption (IDE) Process

By Nick Tippmann on March 31, 2021

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...

Greenlight Guru Medical Device Blog