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Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care - Featured Image

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — ...
Preparing for EUDAMED - Europe’s Medical Device Database - Featured Image

Preparing for EUDAMED - Europe’s Medical Device Database

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices ...
Ultimate List of ISO Standards for Medical Devices - Featured Image

Ultimate List of ISO Standards for Medical Devices

The International Standardization Organization (ISO) is an independent, non-governmental organizatio...
Why Usability Matters - Featured Image

Why Usability Matters

Usability is essential. If you design something, anything used by humans, it needs to be designed fo...
Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices - Featured Image

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulatio...
Explaining IVDR Classification for In Vitro Medical Devices - Featured Image

Explaining IVDR Classification for In Vitro Medical Devices

The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the...
A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology - Featured Image

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transfo...
ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide - Featured Image

ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide

Once a medical device has been designed, developed, and manufactured to specifications, it may feel ...
How to Approach Corrective Action Requests with Medical Device Suppliers - Featured Image

How to Approach Corrective Action Requests with Medical Device Suppliers

For medical device manufacturers, finding success means setting ourselves up for success with repeat...
What are the Top Compliance Issues Plaguing Medical Device Manufacturers? - Featured Image

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Medical device companies must comply with a list of strict requirements throughout the duration of t...
Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry - Featured Image

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical d...
Failure Mode Effects Analysis: What Is It & When Should You Use It? - Featured Image

Failure Mode Effects Analysis: What Is It & When Should You Use It?

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...

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