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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...
What Medical Device Developers Should Know About Human Factors - Featured Image

What Medical Device Developers Should Know About Human Factors

  Human factors can be a topic rife with confusion for medical device developers. What do they mean?...
Tips for Running Effective Internal Quality Audits - Featured Image

Tips for Running Effective Internal Quality Audits

  How did your last internal quality audit go?
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification - Featured Image

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

We have many different types of companies using Greenlight Guru to help them create a compliant qual...
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification - Featured Image

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...
MyoLyn Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru - Featured Image

MyoLyn Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru

For any startup medical device company, the road to FDA 510(k) clearance can be fraught with any num...
Creating an Effective Quality Culture that Benefits Your Patients - Featured Image

Creating an Effective Quality Culture that Benefits Your Patients

  We all want medical devices that improve the quality of life for patients, right?
Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) - Featured Image

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
Tips, Tricks & Best Practices for Complying with ISO 13485:2016 - Featured Image

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

When it comes to ISO 13485:2016, are you scrambling to meet requirements? Are you trying to figure o...
Greenlight Guru Announces Multi-Level Design Control Software - Featured Image

Greenlight Guru Announces Multi-Level Design Control Software

Functionality enables visibility into multiple workspaces, holistic view of design components and a ...
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

The Greenlight Guru Medical Device Blog

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

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