Medical Device Quality, Regulatory and Product Development Blog

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

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

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

By Jon Speer on May 7, 2018

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

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 ...

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring in all areas (Again)!

By Nick Tippmann on April 23, 2018

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...

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...

How to Ensure Your Quality Management System is Effective and Benefits Patients

By Nick Tippmann on April 19, 2018

When it comes to quality management compliance, would you consider yourself a box checker or a true ...

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

By Jon Speer on April 15, 2018

To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi...

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

By Jon Speer on April 9, 2018

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...

What You Need to Know About Risk Management and Using Post-Market Data

By Jon Speer on March 26, 2018

The aim for any medical device company is always to ensure that the devices they make are safe and e...

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