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

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

By Jon Speer on June 28, 2020

What is the expected process you should follow for your medical device design planning and controls?

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...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020

What is a regulatory strategy? What are the components involved?

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

By Jon Speer on May 24, 2020

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

By Nick Tippmann on May 20, 2020

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

By Jon Speer on May 17, 2020

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

By Nick Tippmann on May 13, 2020

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020

What does the 510(k) process involve? How should medical device companies know if this is the right ...

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

By Jon Speer on May 3, 2020

The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends