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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 to start the Verification & Validation (V&V) process. It implies maturity...

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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...

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Speed versus Scale in Contract Manufacturing manufacturing Jun 15, 2022

What is your manufacturing strategy? There are several options to consider. Sometimes it makes sense to engage a large CMO early, whereas other times it makes sense to launch manufacturing with a...

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5 Steps to a Smooth Manufacturing Transfer in Medtech manufacturing Dec 13, 2021

Many new companies have a business model based on transitioning their product to high-volume manufacturing and distribution. Unfortunately, this is more complex than breaking out the parts from a...

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