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Medical Device Design & Development Strategy
From user needs to CE marking: why traceability isn't optional
In MedTech, every requirement must exist for a reason. That reason can be:
A user need
A standard
A regulation
A design constraint
A clinical risk
And yet... many design inputs sit in documents with no link to where they came from.
That’s a risk.
Not just for compliance - but for safety, usability, and performance.
Download our guide now for more details!
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