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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...
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...
Top 100 Medical Device Acronyms & Terminology You Need to Know - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
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...
EUA 101: What is Emergency Use Authorization and How can my Device get Authorized? - Featured Image

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...
How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices - Featured Image

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...
[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...
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD) - Featured Image

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

In this modern digital world, did you know that most medical devices are not connected to the Intern...
How to Leverage IEC 62304 to improve SaMD Development Processes - Featured Image

How to Leverage IEC 62304 to improve SaMD Development Processes

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...
Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...

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