Home
Services
Training and Certification of Persons
Instructor-led Courses
Medical Device Management System
Medical Device Single Audit Program Awareness Training

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) AWARENESS TRAINING

Be prepared for a MDSAP audit

//Contact Us

LIVE VIRTUAL TRAINING SCHEDULE

26th June 2020: Medical Device Single Audit Program (MDSAP) Awareness Training
9 am to 6 pm | 1 Day

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
FAQs
1. How do I enroll for the course?
  To enroll, fill out the form accordingly.
2. What is the course methodology?
  Participants will learn through role plays, case studies, group exercises, scenarios and discussions.
3. Are there any tests in the middle of the course?
  There are no in-between assessments, but case studies will be included in the course.
4. Can I get a refund if I cancel my enrollment?
  Yes, please contact us at [email protected] for more details. Terms and conditions apply.
5. Can I also attend E-learning courses on top of attending the instructor-led course?
  Yes, you can register to any e-learning courses. If you have special requirements, please contact us at [email protected] and we can customise a suitable package for you.
6. Upon completion of the course, would I get a certificate for completion?
  Yes, you will receive a certificate of completion at the end of the course.
7. Who developed the course and what are their qualifications?
  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. The experts also undergo relevant upskilling programmes, benefitting from TÜV SÜD’s 150 years of expertise and global heritage.
To contact someone from TÜV SÜD, you may email us at [email protected].

To know more about TÜV SÜD, please click here.

FIND OUT MORE ABOUT THIS COURSE

Title

Yes, I would like to receive marketing information from TÜV SÜD Indonesia and other TÜV SÜD legal entities relating to their products and services.

I may withdraw my consent at any time with future effect. For further details, refer to the privacy notice. For more information about TÜV SÜD and it's affiliates, refer to list of TÜV SÜD affiliates.

* mandatory fields

Select Your Location

Global

Americas

Asia

Europe

Middle East and Africa