The 4 Most Common Mistakes in the Risk Acceptance Matrix
In the past, medical device manufacturers have used risk acceptance matrices with large green areas where the occurrence of damage was...
The 4 Most Common Mistakes in the Risk Acceptance Matrix
Vietnam – a Sourcing Country for the Medical Device Industry?
Risk acceptance threshold: How many deaths are we willing to accept?
FMEA is not risk analysis!
Test Method Validation (TMV) in Medical Device Manufacturing
Performance Qualification (PQ) – Run 3 batches and ready, right?
Cultural differences… And how to not let them become an issue by using Erin Meyer's culture map
Operational Qualification (OQ)
Medical Device Manufacturing: Are you familiar with Process Validation?
Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6