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The Future of Cybersecurity - Featured Image

The Future of Cybersecurity

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers nee...
Software Bill of Materials: What to Know About SBOMs for Medical Devices - Featured Image

Software Bill of Materials: What to Know About SBOMs for Medical Devices

On May 12, 2021, President Biden signed the Executive Order On Improving the Nation’s Cybersecurity....
3 Medical Device Security Challenges (and Solutions) - Featured Image

3 Medical Device Security Challenges (and Solutions)

Technological innovations in and around the medical device industry have made it possible for compan...
Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know - Featured Image

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Your device history record (DHR) is one of the final forms of documentation you’ll need before your ...
Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device - Featured Image

Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device

Biocompatibility testing is one of the fundamental means of ensuring medical devices are safe for pa...
Understanding Product Realization under ISO 13485 - Featured Image

Understanding Product Realization under ISO 13485

Medical devices always begin the same way: as an idea. And while ideas are an invaluable resource, t...
What Does the IDE Application Process Involve? - Featured Image

What Does the IDE Application Process Involve?

When medical device manufacturers hope to bring a new and perhaps revolutionary medical device to ma...
What are the SaMD Requirements from FDA? - Featured Image

What are the SaMD Requirements from FDA?

The market for software as a medical device (SaMD) is growing rapidly as more companies see the poss...
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 ...
Software as a Medical Device: Definitions, Examples & Regulatory Framework - Featured Image

Software as a Medical Device: Definitions, Examples & Regulatory Framework

Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...
3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers - Featured Image

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...
Goodbye EN 1041. Hello ISO 20417:2021. - Featured Image

Goodbye EN 1041. Hello ISO 20417:2021.

When you’re trying to bring a new medical device to market, it’s normal to be focused on actually bu...

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