Implementing and Maintaining PMS and Performance Evaluation under the IVDR – Webinar

Celegence - https://www.celegence.com/services/ivdr/ - is a global life science consulting firm focused solely on regulatory and quality compliance. We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation. The EU In Vitro Diagnostic Devices Regulation (IVDR) brings together previously disparate components of the quality system and requires them to interoperate in a highly synchronous manner with Post Market Surveillance (PMS) driving the documentation cycle for each product in a manufacturer’s portfolio. This featured presentation will be led by Celegence’s Regulatory Affairs Subject Matter Expert for Medical Devices and IVDs James Shearn. There will be a Q/A session following the presentation. Contact us at [email protected] to learn more.