MedTech Blog

Mar 11, 20243 min read

How The EU MDR Changed The Landscape of Process Validation

Spoiler: The EU MDR did not invent Process Validation; nor did it introduce the requirement for Test Method Validation. How the EU MDR...

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Mar 9, 20235 min read

Technical Understanding in MedTech – 6 Reasons Why You Must Have a Good Technical Understanding to Validate Your Processes

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Jul 19, 20222 min read

Performance Qualification (PQ) – Run 3 batches and ready, right?

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Jan 11, 20225 min read

Operational Qualification (OQ) – The fun part of medical device Process Validation!

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Nov 2, 20213 min read

Installation Qualification (IQ) in MedTech – Ticking off as necessary evil or to build a strong foundation?

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Oct 3, 20215 min read

IQ, OQ, PQ – What's really behind these acronyms that everyone believes to know – Process Validation in Medical Device Manufacturing.

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