MedTech Blog

Visual inspection is a cornerstone of quality assurance in the medical device industry, ensuring product integrity, patient safety, and...

Test methods don't fall from the sky – we have to develop them. We often talk about test method validation, but we rarely address test...

Let's delve into the topic of process variation and the importance of adequate sample sizes.

Spoiler: The EU MDR did not invent Process Validation; nor did it introduce the requirement for Test Method Validation. How the EU MDR...