<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

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

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

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...
How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends - Featured Image

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

Medical device companies are among the most important players in the world’s response to COVID-19.
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers - Featured Image

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

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

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
How Software Architecture Enables Faster Release of New Clinical Tests to the Market - Featured Image

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

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...
How to Integrate Usability into your Medical Device - Featured Image

How to Integrate Usability into your Medical Device

Medical device usability is a critical, yet confusing component of medical device design, developmen...
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020 - Featured Image

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...
Integrating Human Factors into Design Controls to Improve Patient Outcomes - Featured Image

Integrating Human Factors into Design Controls to Improve Patient Outcomes

The relationship between human factors and design controls often creates confusion in the medical de...
How and When to Consider Human Factors - Featured Image

How and When to Consider Human Factors

When should you begin to consider human factors with your medical device design and development effo...
Design Validation vs. Human Factors Validation - Featured Image

Design Validation vs. Human Factors Validation

  Human factors and risk create a lot of confusion in the medical device industry. What do you need ...
How Human Factors Impact Your Medical Device - Featured Image

How Human Factors Impact Your Medical Device

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

Our Most Popular Posts

Topics

See More Topics...