Latest / Medical Device made Easy Podcast
Validation & Supplier Management in MedTech
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.
Key topics discussed include:
Test Method Validation: definition, regulatory expectations, and when it is required
FDA warning letters and the risks of non-compliant validation approaches
Common pitfalls and best practices for Test Method Validation
Process Validation and Packaging Validation
The…
The skinny
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