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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...
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
How to Apply IEC 62304 Requirements for Medical Device Software - Featured Image

How to Apply IEC 62304 Requirements for Medical Device Software

If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical ...
Navigating the MedTech Cybersecurity Ecosystem - Featured Image

Navigating the MedTech Cybersecurity Ecosystem

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the U...
Answer these 3 questions before developing Software as a Medical Device - Featured Image

Answer these 3 questions before developing Software as a Medical Device

Health and life science organizations are constantly striving to improve patient centricity and to o...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape - Featured Image

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA - Featured Image

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...
What is FDA's Approach to Regulating AI/ML in Software as a Medical Device? - Featured Image

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

The FDA has released a discussion guideline and request for feedback regarding changes in the certif...
Protecting the Intellectual Property of your Medical Device Technology - Featured Image

Protecting the Intellectual Property of your Medical Device Technology

Should you have patent protection for your medical device technology? Should you keep your secret sa...

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