Be prepared for a MDSAP audit
Medical Device Single Audit Program (MDSAP) is a way to develop, manage and supervise an audit program that allows a single regulatory audit of a manufacturer conducted by a recognised Auditing Organisation to satisfy the needs of several regulatory jurisdictions. It is based on ISO 13485 and specific regulatory requirements of participating countries.
Duration: 1 - day course
WHAT WILL YOU LEARN FROM THE COURSE?
At the end of this course, participants will be able to:
• know the fundamentals of MDSAP
• understand MDSAP Audit structure and core processes
• learn MDSAP requirements
Topics to be covered in this course include:
• MDSAP overview and objectives
• Benefits of MDSAP
• Goals and Strategies of MDSAP audit program
• MDSAP requirements
• Audit process structure and audit task
• MDSAP nonconformity grading system
• Impact of audit model to organisation
• Documentation and reporting
WHAT IS THE COURSE METHODOLOGY?
Participants will learn through lectures, case studies, group exercises and discussions.
WHO SHOULD TAKE THE COURSE?
This course is specially designed for:
• Quality Assurance and Regulatory Affairs professionals
• Internal auditors
• Quality engineers
• Manufacturing engineers within medical device industry
WHO IS THE COURSE ADVISOR?
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
World-class training – by learning from TÜV SÜD’s industry experts and training specialists
Interactive learning style – with interactive formats such as lectures, illustrations and simulations are used
Networking opportunity – where you can meet and build network with like-minded individuals at our instructor-led training
Gain a competitive edge – by getting trained by experts known in the fields of safety, security and sustainability