Zoonoses are infectious diseases caused by bacteria, parasites, fungi, prions, or viruses that can be transmitted reciprocally between animals and humans. The transmission of zoonoses by medical devices manufactured from or with materials of animal origin is an additional aspect of their biological safety.
In this web-seminar we will introduce the risk management process according to (EN) ISO 22442-1. The requirements for the assessment process of transmissibility of zoonoses will be explained. Examples are used to highlight the pathogens of zoonoses and their susceptibility to the manufacturing process of medical devices. Reporting in conformity with the standards is dealt with. In particular, the challenges and pitfalls of assessment will be addressed.
Content:
- Regulatory background information
- Detailed information on zoonoses
- Elimination of zoonotic agents
- Inactivation of zoonotic agents and verification of inactivation
- Risk analysis and risk mitigation
- Information on the procedure, content, and structure of expert declarations to meet regulatory requirements
Details
◾ Persons responsible for regulatory affairs
◾ Representatives of authorities, decision-makers, consultants