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

3 Systems of Risk for Medical Devices from FDA

By Nick Tippmann on April 7, 2021

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

By Nick Tippmann on March 21, 2021

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices f...

Prioritizing Medical Device Reimbursement During Product Development

By Nick Tippmann on February 3, 2021

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...

What are the Strategic Priorities for CDRH in 2021?

By Nick Tippmann on January 20, 2021

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) a...

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

By Nick Tippmann on January 6, 2021

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...

Why Biocompatibility Should be Addressed by Every Medical Device Company

By Nick Tippmann on November 4, 2020

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...

What is a Multiple Function Device?

By Nick Tippmann on September 30, 2020

What is a multiple function device? From a high level, it’s a product with at least one portion that...

Challenges related to Home Use Devices

By Nick Tippmann on September 10, 2020

What could go wrong as more medical device products are used at home and in similar non-traditional ...

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

By Nick Tippmann on September 2, 2020

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...

How Jon Speer Met His Most Frequent Guest: Mike Drues

By Nick Tippmann on August 26, 2020

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

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