MedTech Blog

Jul 19, 20222 min read

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

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

Apr 1, 20226 min read

Cultural Differences in International Business… And How To Not Let Them Become an Issue

Cultural Differences… And How To Not Let Them Become an Issue by Using Erin Meyer's Culture Map

Jan 11, 20224 min read

Operational Qualification (OQ)

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

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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.

Sep 20, 20215 min read

Process Validation Sample Size – Cpk of 1.33 is not enough!

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Sep 7, 20215 min read

Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6

Statistical Tolerance Interval in MedTech – Explained based on ISO 16269-6