MedTech Blog

Mar 113 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...

Mar 9, 20235 min read

6 Reasons Why Your Technical Understanding is Essential for Process Validation in MedTech

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

Jul 19, 20222 min read

Performance Qualification (PQ) – Run 3 Batches And Ready, Right?

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

Jan 11, 20224 min read

Operational Qualification (OQ)

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

1,763 views0 comments

Nov 2, 20213 min read

Installation Qualification (IQ)

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

Oct 3, 20214 min read

Process Validation in Medical Device Manufacturing: How Familiar Are You With IQ, OQ, and PQ?

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