Challenges in Virus Clearance Studies Design and Execution for Tissue-Based Medical Devices

Raw materials of biological origin, used to manufacture tissue-based medical devices, may contain viral or prion agents dangerous to human health (zoonosis). EU MDR as well as US FDA require manufacturers of medical devices to demonstrate the ability of their manufacturing processes to inactivate and/or remove such infectious particles, according to ISO 22442-3 prescriptions and 2019 FDA guidance for industry recommendations.

A comprehensive documental assessment and a robust experimental design are needed in order to clearly identify zoonosis risk and the potential virus clearance steps in the manufacturing process under investigation.

The aim of this webinar is to provide important insights on how to identify and validate viral clearance steps by means of diverse case studies in order to ensure the safety of tissue-based in a robust way and in compliance to the current EU and US requirements.