Simon FögerMar 113 minHow The EU MDR Changed The Landscape of Process ValidationSpoiler: The EU MDR did not invent Process Validation; nor did it introduce the requirement for Test Method Validation. How the EU MDR...
Simon FögerMar 9, 20235 min6 Reasons Why Your Technical Understanding is Essential for Process Validation in MedTechTechnical Understanding in MedTech – 6 Reasons Why You Must Have a Good Technical Understanding to Validate Your Processes
Simon FögerJul 19, 20222 minPerformance Qualification (PQ) – Run 3 Batches And Ready, Right?Performance Qualification (PQ) – Run 3 batches and ready, right?
Simon FögerJan 11, 20224 minOperational Qualification (OQ)Operational Qualification (OQ) – The fun part of medical device Process Validation!
Simon FögerNov 2, 20213 minInstallation Qualification (IQ)Installation Qualification (IQ) in MedTech – Ticking off as necessary evil or to build a strong foundation?
Simon FögerOct 3, 20214 minProcess 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.
