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

Why Usability Matters

By Nick Tippmann on November 24, 2021

Usability is essential. If you design something, anything used by humans, it needs to be designed fo...

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

By Nick Tippmann on November 17, 2021

Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transfo...

3 Non-negotiables for Managing Business Risk as a Medical Device Company

By Taylor Brown on November 11, 2021

How seriously do you take risk management? This may seem like an inane question, especially for a pr...

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...

7 Project Management Tips

By Jon Speer on October 28, 2021

When I began my medical device career, I started as a product development engineer. Part of the role...

Project Management for Product Development of Medical Devices

By Nick Tippmann on October 27, 2021

How should you approach project management for medical device product development ? Stop managing yo...

IEC 62366 Explained: What You Need To Know About Usability Engineering

By Etienne Nichols on October 24, 2021

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on desi...

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

By Etienne Nichols on October 10, 2021

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...

Creating a Quality Manual That Complies with ISO 13485

By Taylor Brown on October 3, 2021

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...

How to Execute a Successful Product Launch

By Jon Speer on September 26, 2021

Bringing a medical device to market can take anywhere from three to seven years, on average. The des...

Debunking 4 Commonly Held Design Control Myths

By Jon Speer on September 17, 2021

The design control struggle is real.What is the struggle, you ask? Design controls are not being use...

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

By Jon Speer on September 13, 2021

So you need to make a change to your medical device, what now?

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