MedTech Blog

Attribute Agreement Analysis (Go/No Go Gage or Pass/Fail Test Systems)

In this blog post we discuss the validation approach of a Pass/Fail Test System aka Attribute Agreement Analysis or Go/No Go Gage. An...

Destructive Test Methods: Gage Reproducibility Study (TMV of Continuous Destructive Measurements)

In the previous blog post about Gage R&R (with Minitab) aka Test Method Validation for continuous non-destructive measurements, we...

Conducting a Gage R&R Study with Minitab (Explained with a Practical Example)

In the previous blog post about Test Method Validation, we already discussed different types of Test Method Validations, depending on the...

Test Method Validation (TMV) in Medical Device Manufacturing

You may be thinking, "OMG, what more do we need to validate? Is this still not enough?" Well, no, it isn't. Fortunately, we really need...