Audit findings, launch delays, costly recalls, and lost trust – these are the consequences of unvalidated test methods in MedTech. There’s a good reason why Test Method Validation (TMV) is a regulatory requirement: it’s essential for product safety.

 

Still, many companies assume that testing alone is enough – it’s not. Without validated test methods, your data cannot be trusted, risking defective products reaching the market.

 

Testing without validation gives a false sense of security – and auditors know it. From missing statistical sample sizes to unclear acceptance criteria and inconsistent documentation, the pitfalls are everywhere. Each one can lead to findings, rework, or market delays.

 

Avoid costly mistakes and ensure product safety from day one.

 

Our Test Method Validation Training gives you a clear, structured roadmap for developing and validating test methods in line with EU and FDA requirements.

 

Learn directly from a seasoned MedTech expert who has implemented hundreds of TMV projects worldwide. 

Gain the confidence to defend your validation decisions in any audit and ensure your products meet the highest standards of safety and compliance.