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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 ...
Meet a Guru: Wade Schroeder - Featured Image

Meet a Guru: Wade Schroeder

By Nick Tippmann on August 19, 2020
What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of m...
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...
Meet a Guru: Tom Rish - Featured Image

Meet a Guru: Tom Rish

By Nick Tippmann on August 5, 2020
What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge.
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...
Protecting the Intellectual Property of your Medical Device Technology - Featured Image

Protecting the Intellectual Property of your Medical Device Technology

By Nick Tippmann on July 22, 2020
Should you have patent protection for your medical device technology? Should you keep your secret sa...
Meet a Guru: Jesseca Lyons - Featured Image

Meet a Guru: Jesseca Lyons

By Nick Tippmann on July 15, 2020
What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...
How to Build a QMS for a Medical Device - Featured Image

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...
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...
What is Regulatory Due Diligence for Medical Devices? - Featured Image

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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