F. Regulatory and Clinical Development
Regulatory Requirements for Medical Devices
Introduces device classification, essential safety and performance requirements, quality-system expectations, technical documentation, labelling, conformity evidence, registration and post-market responsibilities.
Duration3 hours
Best ForMedical-device companies, importers, regulatory and quality staff
FormatLive course or customized corporate training
Introduces device classification, essential safety and performance requirements, quality-system expectations, technical documentation, labelling, conformity evidence, registration and post-market responsibilities. Content can be customized to the target market.