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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...
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...
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...
3 Non-negotiables for Managing Business Risk as a Medical Device Company - Featured Image

3 Non-negotiables for Managing Business Risk as a Medical Device Company

How seriously do you take risk management? This may seem like an inane question, especially for a pr...
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...
What’s the Difference Between Clinical Evaluation and Clinical Investigation? - Featured Image

What’s the Difference Between Clinical Evaluation and Clinical Investigation?

Within the myriad of regulations and standards governing medical devices, there are a number of simi...
IEC 62366 Explained: What You Need To Know About Usability Engineering - Featured Image

IEC 62366 Explained: What You Need To Know About Usability Engineering

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on desi...
Medical Device 3D Printing: Should You Make the Move? - Featured Image

Medical Device 3D Printing: Should You Make the Move?

The medical device industry has grown immensely over the past several decades. But with new technolo...
Clinical Testing for Medical Devices: What US Manufacturers Need to Know - Featured Image

Clinical Testing for Medical Devices: What US Manufacturers Need to Know

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...
Ultimate Guide to QA & RA in Medical Device 3D Printing - Featured Image

Ultimate Guide to QA & RA in Medical Device 3D Printing

This document aims to guide users in the medical device industry through every stage of the product ...

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