Medical Device Quality, Regulatory and Product Development Blog

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

How to Approach Verification and Validation for Cloud Software

By Nick Tippmann on April 15, 2020

Why is verification and validation (V&V) confusing and challenging for many medical device professio...

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

By The RND Group on April 12, 2020

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...

What are the Changes to ISO 14971:2019 & TR 24971?

By Jon Speer on April 12, 2020

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

By Nick Tippmann on April 10, 2020

During the COVID-19 crisis, medical device companies are improving and saving the lives of healthcar...

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

By Nick Tippmann on April 8, 2020

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this r...

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

By Jon Speer on April 5, 2020

COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

By Nick Tippmann on April 4, 2020

During unprecedented times, medical device companies are finding themselves facing unusual challenge...

How to Integrate Usability into your Medical Device

By Nick Tippmann on April 1, 2020

Medical device usability is a critical, yet confusing component of medical device design, developmen...

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

By Jon Speer on March 29, 2020

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

By Nick Tippmann on March 26, 2020

In this modern digital world, did you know that most medical devices are not connected to the Intern...

Medical Device Companies - Top 100 in 2020 (Free Chart)

By Nick Tippmann on March 24, 2020

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...

Greenlight Guru Medical Device Blog