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MedTech Mindset Blog

The Latest MedtechĀ Insights from Archimedic.

5 Essential Checks before 'Design Freeze' design manufacturing project management prototyping quality management v&v Jun 19, 2024

Design Freeze is a significant milestone in MedTech. It's the point when you're ready toĀ start the Verification & Validation (V&V) process.Ā It implies maturity ofĀ yourĀ technical design and also your d...

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User Needs vs Design Inputs: It's about Viewpoint quality management v&v Apr 01, 2024

Written by Christopher Scholl

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Ever built the wrong medtech device?

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I’ve worked at a number of medical device companies and each one took a different approach to writing User Needs and Design I...

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EVT - It's like TSA precheck for Verification & Validation manufacturing project management quality management v&v May 02, 2023

Picture this -- you've raced to the airport and found yourself at the end of a massive security line. You do the truffle shuffle with shoes off, belt off, keys out, laptop out, while the security agen...

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