<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

By Nick Tippmann on June 23, 2021
A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

By Nick Tippmann on June 14, 2021
What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
Examining the HHS Proposal for Premarket Notification Exemptions - Featured Image

Examining the HHS Proposal for Premarket Notification Exemptions

By Nick Tippmann on June 7, 2021
What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...
3 Systems of Risk for Medical Devices from FDA - Featured Image

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? - Featured Image

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 - Featured Image

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? - Featured Image

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 - Featured Image

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 - Featured Image

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? - Featured Image

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 - Featured Image

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 - Featured Image

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...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

Our Most Popular Posts

Topics

See More Topics...
© 2021 Greenlight Guru
Third party trademarks, logos and trade names appearing on the site are the property of their respective owners. Legal