Guides

Clear Design Inputs are vital in medical device development under ISO 13485 or FDA regulations. Use the CUVC framework:

• Complete: Cover ...

Regulatory expectations in MedTech are rising, with costs increasing by 50% for medical devices and 70% for IVDs. Documentation is ...

Your medical device can collect data. But can it transmit, analyze, and present it securely?

Remote Patient Monitoring (RPM) isn’t just ...

Remote Patient Monitoring (RPM) is more than a data stream from a wearable.

It's a clinically grounded workflow one that requires ...

Did you design it right? Or did you design the right thing?

These two questions might sound similar, but in the ...

A design output is the tangible evidence that a design element has been implemented, the drawings, specifications, procedures, or code… ...

Here is a practical guide to write your User needs & Requirements during design input

• UN & Req. are a critical ...

AI is a tool. The brain is still yours.

Matrix Mind just helps you use it better.

So what makes Matrix Mind ...

ISO 14971 says “manage risk.” But how do you analyze it?

Knowing these techniques is one thing.

Applying them across design, verification, ...