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5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

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 - Featured Image

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

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...
The Essential Guide to Preparing your QMS for EU MDR - Featured Image

The Essential Guide to Preparing your QMS for EU MDR

How prepared is your quality management system for the new requirements of EU MDR for medical device...
Improving the Colon Cancer Screening Experience - Featured Image

Improving the Colon Cancer Screening Experience

Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasi...
EU MDR: Not All Doom and Gloom - Featured Image

EU MDR: Not All Doom and Gloom

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...
Qualifying Your Suppliers Using a Risk-based Approach - Featured Image

Qualifying Your Suppliers Using a Risk-based Approach

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 - Featured Image

Biocompatibility Nuances and its Impact on Medical Devices

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...
How to Write Effective SOPs for Medical Devices - Featured Image

How to Write Effective SOPs for Medical Devices

Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...
Advancing MRI Technology As We Know It Today - Featured Image

Advancing MRI Technology As We Know It Today

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 - Featured Image

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

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 - Featured Image

8 Questions About the European MDR Answered

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 - Featured Image

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

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

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

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