The 5 Most Common Calibration Pitfalls You Should Avoid in MedTech
A quick search of the FDA warning letter database shows more than a dozen entries around 21 CFR 820.72. Calibration is a well-understood...
The 5 Most Common Calibration Pitfalls You Should Avoid in MedTech
Why Your Suppliers Do Not Need an ISO 13485 Certification
6 Reasons Why Your Technical Understanding is Essential to Validate Processes in MedTech
Test Method Validation of Pass/Fail Test Systems
Test Method Validation of Continuous Destructive Measurements
Test Method Validation of Continuous Non-Destructive Measurements
Test Method Validation (TMV) in Medical Device Manufacturing
Performance Qualification (PQ) – Run 3 batches and ready, right?
Operational Qualification (OQ)
Installation Qualification (IQ)
Medical Device Manufacturing: Are you familiar with Process Validation?
Process Validation Sample Size – Cpk of 1,33 is not enough!
Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6