MDSAP for the GB and EU Manufacturer Course & Certification

MDSAP for the GB and EU Manufacturer provides a practical overview of the Medical Device Single Audit Program (MDSAP) and its application to manufacturers operating across Great Britain and the European Union. It helps learners understand the MDSAP audit model, participating jurisdictions, certification scope, audit planning, certification lifecycle, surveillance, special and unannounced audits, nonconformity grading, corrective actions, notifications, and scope extensions.
This MDSAP Course & Certification covers the MDSAP Audit Model and its primary and supporting processes, Auditing Organisation requirements, audit duration and lead-time considerations, certification and surveillance activities, regulatory notifications, and the management of audit findings. The course also explains how MDSAP interacts with EU MDR/IVDR, UKCA and GB CE-mark transitional arrangements, including how MDSAP audit evidence may be considered by notified bodies under MDCG 2020-14. Upon successful completion, learners receive a certification demonstrating their understanding of MDSAP requirements and their practical application within GB and EU medical device regulatory environments.

• Medical Device Regulatory Affairs Professionals
• Quality Assurance and Quality Management Professionals
• MDSAP and Audit-Readiness Professionals
• Compliance and Regulatory Professionals
• Medical Device Manufacturers and QMS Owners
• Professionals Working with Notified Bodies and Approved Bodies
• Manufacturing, Supplier Quality and Post-Market Surveillance Professionals
• Anyone involved in preparing for, managing or maintaining MDSAP certification and GB or EU regulatory compliance