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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...
How to Validate Cloud-based Software Tools - Featured Image

How to Validate Cloud-based Software Tools

Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD) - Featured Image

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem - Featured Image

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

What impact will the EU MDR changes have on the medical device ecosystem?
How to Approach Verification and Validation for Cloud Software - Featured Image

How to Approach Verification and Validation for Cloud Software

Why is verification and validation (V&V) confusing and challenging for many medical device professio...
How Software Architecture Enables Faster Release of New Clinical Tests to the Market - Featured Image

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...
FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing - Featured Image

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...

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