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How to Write a Nonconformance Report - Featured Image

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020
Nonconformance is a word no quality manager wants to hear.
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...
How Jon Speer Met His Most Frequent Guest: Mike Drues - Featured Image

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 ...
What are the Audit Etiquette Rules I Should be Following? - Featured Image

What are the Audit Etiquette Rules I Should be Following?

By Nick Tippmann on August 12, 2020
Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020
You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
Addressing Clinical Trial Challenges & Concerns during COVID-19 - Featured Image

Addressing Clinical Trial Challenges & Concerns during COVID-19

By Nick Tippmann on July 29, 2020
The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst...
What is FDA's Approach to Regulating AI/ML in Software as a Medical Device? - Featured Image

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

By The RND Group on July 26, 2020
The FDA has released a discussion guideline and request for feedback regarding changes in the certif...
Top 100 Medical Device Acronyms & Terminology You Need to Know - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020
In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
Meet a Guru: Taylor Brown - Featured Image

Meet a Guru: Taylor Brown

By Nick Tippmann on July 1, 2020
What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over e...
How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations - Featured Image

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

By Jon Speer on June 28, 2020
What is the expected process you should follow for your medical device design planning and controls?

The Greenlight Guru Medical Device Blog

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

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