Medical Device Single Audit Program (MDSAP): Requirements and Preparation
- Learn the basics of MDSAP — get an understanding of the concepts, audit structure and benefits of MDSAP.
- Understand the key requirements of MDSAP to facilitate the market access of your medical devices.
- Learn to prepare effectively a MDSAP audits and detect non-conformities more easily and quickly.
This course is ideal for:
- Medical device manufacturers and exporters
- Quality Management Professionals
- Regulatory Affairs Professionals
- External and internal auditors
- Introduction and general requirements
- The MDSAP audit model
- New aspects by the MDSAP audit approach:
- Grading system of non-conformities (1-5)
- Determine the audit duration with two tools (procedure, Excel workbook)
- Country specific requirements
- Tips to prepare a MDSAP audit
The Medical Device Single Audit Program (MDSAP) model was developed by the International Medical Device Regulators Forum (IMDRF). IMDRF’s goal for developing a single audit model was to promote greater alignment and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. The MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities. MDSAP audits can only be carried out by authorized auditing organizations.
International partners that are participating in the MDSAP include: Australia, Brazil, Canada, Japan, and USA.
In this course, you will discover the fundamentals of MDSAP and will learn to interpret the MDSAP audit approach correctly. You will gain an understanding of MDSAP Audit structure and core processes. In addition, you will discover how to apply and align MDSAP to the internal audit program.
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
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.
TÜV SÜD Academy certificate of attendance
No requirements are necessary.