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Guides
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, ...
Risk in Excel.
Requirements in Word.
Tests in SharePoint / dropbox.
Sound familiar?
That’s the classic workflow.
It’s how most medtech teams start. It works.
Until ...
From user needs to CE marking: why traceability isn't optional
In MedTech, every requirement must exist for a reason. That reason ...
Here are 12 practical tips for improving design control in MedTech product development.
Especially useful if you're managing requirements, verification/validation tests, ...
How to classify your medical device software per IEC 62304?
Not all software is equal.
IEC 62304 defines 3 software safety ...
Traceability connects ISO 14971 and IEC 62304.
Without it, risk control is incomplete.
Risk management only becomes meaningful when each identified risk ...