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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

By Nick Tippmann on May 25, 2018
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

By Nick Tippmann on May 25, 2018
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

By Nick Tippmann on May 25, 2018
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

By Nick Tippmann on May 20, 2018
  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)

By Nick Tippmann on May 15, 2018
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)

By Edwin Bills, ASQ Fellow, RAC on May 14, 2018
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

By Nick Tippmann on May 8, 2018
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

By Nick Tippmann on May 7, 2018
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

By Jon Speer on May 7, 2018
FDA Warning Letters and Form 483 Observations - What’s the Difference? - Featured Image

FDA Warning Letters and Form 483 Observations - What’s the Difference?

By Jon Speer on April 30, 2018
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
Helping to Prepare Biomedical Engineers Entering the Workforce - Featured Image

Helping to Prepare Biomedical Engineers Entering the Workforce

By Nick Tippmann on April 24, 2018
Students offer hope for our future. They will be developing products that can save our lives, or at ...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018
Every medical device developer would like to take the fastest path to market, right? Sometimes the k...

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