Medical Device Quality, Regulatory and Product Development Blog

Greenlight Guru Launches Visualize to Redefine the Medical Device Industry’s Approach to Closed-Loop Traceability

By Nick Tippmann on September 21, 2020

New machine learning powered capabilities provide device makers with instant visibility into the con...

Introducing Greenlight Guru Visualize: Quality at a Bird’s Eye View

By Nick Tippmann on September 20, 2020

Most people are visual learners. In fact, it has been reported that visuals can improve learning by ...

CAPA Process - Step-by-Step Instructions [Infographic]

By Jon Speer on September 13, 2020

CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...

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 ...

Quality Assurance vs. Quality Control in the Medical Device Industry

By Jon Speer on September 6, 2020

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...

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...

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

By Jon Speer on August 30, 2020

In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...

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 ...

Document Control for Medical Device Companies: The Ultimate Guide

By Jon Speer on August 23, 2020

According to the original data findings of our 2020 State of Medical Device Product Development and ...

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...

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...

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...

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