
Risk acceptance threshold: How many deaths are we willing to accept?
There are increasing reports from the field that insufficiently justified risk acceptance limits have led to problems with product...
Risk acceptance threshold: How many deaths are we willing to accept?
3 strategies to make your supply chain more resilient as a MedTech-SME in 2023
The underestimated value of "clinical benefit" in medical device risk management
How to minimize risks "as far as possible"!
FMEA is not risk analysis!
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
Performance Qualification - Run 3 batches and ready, right?
Cultural differences… And how to not let them become an issue!
Operational Qualification
Installation Qualification
Are you familiar with Process Validation?
Cpk of 1,33 is not enough!
Statistical Tolerance Intervals - Explained simply and practically based on ISO 16269-6