Archimedic Blog

Introduction

Design Freeze is a significant milestone in MedTech. It's the point when you're ready to start the Verification & Validation (V&V) process. It implies maturity of your technical design a...

Ever built the wrong medtech device? I’ve worked at a number of medical device companies and each one took a different approach to writing User Needs and Design Inputs. And it’s no wonder—FDA CFR and ...

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...