Medical Device Quality, Regulatory and Product Development Blog

5 Most Common Mistakes Made When Implementing ISO 14971

By Jon Speer on June 2, 2019

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...

Greenlight Guru In the Classroom: A University's Real-world Approach

By Nick Tippmann on May 29, 2019

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...

The Essential Guide to Preparing your QMS for EU MDR

By Jon Speer on May 27, 2019

How prepared is your quality management system for the new requirements of EU MDR for medical device...

Improving the Colon Cancer Screening Experience

By Nick Tippmann on May 24, 2019

Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasi...

EU MDR: Not All Doom and Gloom

By Nick Tippmann on May 22, 2019

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...

Qualifying Your Suppliers Using a Risk-based Approach

By Jon Speer on May 19, 2019

This notion of risk-based processes within quality systems is something that has become part of our ...

Biocompatibility Nuances and its Impact on Medical Devices

By Nick Tippmann on May 15, 2019

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...

How to Write Effective SOPs for Medical Devices

By Jon Speer on May 12, 2019

Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...

Advancing MRI Technology As We Know It Today

By Nick Tippmann on May 10, 2019

The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's lea...

How to Make De Novo a Viable Option for your Medical Device

By Nick Tippmann on May 9, 2019

Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...

8 Questions About the European MDR Answered

By Jon Speer on April 30, 2019

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

By Nick Tippmann on April 26, 2019

Within the medical device industry, there’s a right way and a wrong way to address quality and compl...

Greenlight Guru Medical Device Blog