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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...
Engineering Change Order: The Role it Plays in the Change Management Process - Featured Image

Engineering Change Order: The Role it Plays in the Change Management Process

Change is just part of life for medical device companies. No device makes it to market without quite...
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...
Greenlight Guru Launches Guru Assist, On-Demand Lifeline to Medical Device Experts - Featured Image

Greenlight Guru Launches Guru Assist, On-Demand Lifeline to Medical Device Experts

New on-demand assistance functionality offers a flexible way to leverage expert medical device suppo...
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...
The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers - Featured Image

The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers

The internet of things (IoT) is a blanket term used to describe the billions of connected objects an...

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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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