MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) AWARENESS TRAINING

Be prepared for a MDSAP audit

Be prepared for a MDSAP audit

ABOUT THE COURSE

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

Prerequisite: None

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.

 

  • What are the benefits of enrolling in this course?
    • 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

 

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