TszWai Woo is a regulatory specialist at IVDeology Ltd. She brings her exceptional regulatory experience from 16 years within the IVD industry to support IVD manufacturers navigate the IVD regulations including CE IVDD, CE IVDR, UKCA and ISO13485 Quality Management Systems
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The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
Presented by Tsz Wai Woo