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

Setting the Record Straight on Usability & Human Factors

By Nick Tippmann on November 3, 2021

What is usability? Human factors? Are they one and the same or different in the medical device indus...

Clinical Testing for Medical Devices: What US Manufacturers Need to Know

By Wade Schroeder on October 21, 2021

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...

7 Documentation Musts for All Software Device Premarket Submissions

By Wade Schroeder on August 8, 2021

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...

How to Build Medical Device Usability Testing and Validation into Your Quality System

By Wade Schroeder on May 2, 2021

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...

Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community

By Nick Tippmann on March 8, 2021

Greenlight Guru Academy will educate and train medical device professionals on everything they need ...

5 Actionable Lessons Learned from the RADx Initiative by NIH

By Nick Tippmann on January 27, 2021

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

By Nick Tippmann on January 5, 2021

Customers benefit from expert advice to lower development costs and save time identifying the right ...

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

By Nick Tippmann on December 2, 2020

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...

What Goes into Designing Devices for Military and Emergency Applications?

By Nick Tippmann on November 25, 2020

There’s one niche market within the device industry that rarely gets the attention it deserves: prod...

Medical Device Biocompatibility 101

By Erica Loring on November 8, 2020

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...

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 ...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

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