Medical Device Quality, Regulatory and Product Development Blog

Why Paper-Based Quality Management Systems are No Longer an Option

By Jon Speer on August 12, 2018

It’s time to face facts: a paper-based quality management system is no longer an option.

How Human Factors Impact Your Medical Device

By Nick Tippmann on August 8, 2018

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...

Medical Device Companies - Top 100 in 2018 (Free Chart)

By Nick Tippmann on August 5, 2018

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

How to Think About Quality and Regulatory as Your Company Scales

By Nick Tippmann on August 1, 2018

As companies transition from being a start-up or small company to a more established business and br...

Challenging “Conventional Wisdom” in Medtech R and D

By Jon Speer on July 29, 2018

The idea of “research versus development” can be highly controversial and much-debated among medic...

How to Design for Compliance with IEC60601

By Nick Tippmann on July 25, 2018

Have you ever designed a medical device that has electrical components? Was it frustrating to go thr...

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

By Jesseca Lyons on July 20, 2018

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

By Nick Tippmann on July 18, 2018

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...

A Guide to Bridging User Needs Into Design Requirements

By Jon Speer on July 16, 2018

“The answers are only as good as the questions we ask!”

Why There is a Need for Multi-Level Design Controls

By Nick Tippmann on July 12, 2018

We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

By Nick Tippmann on July 12, 2018

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

By Connor Remaley on July 10, 2018

Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have ...

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