Medical Device Single Audit Program (MDSAP) Fundamentals and Audit Preparation
Length of Course
1.0 Day
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
Level of Difficulty
Beginner (no knowledge at all of the topic).
Maintaining regulatory and quality compliance across multiple markets is challenging. In addition to meeting stringent regulatory requirements, manufacturers must also submit to regular quality system audits. When operating in multiple markets, this often means a busy audit schedule that can distract from daily operations.
Auditors must also duplicate efforts when evaluating systems that have already been approved by another regulatory body with similar requirements. The Medical Device Single Audit Program (MDSAP) aims to make it easier for manufacturers to comply with harmonized global quality management system (QMS) standards and to reduce the resource burden on the industry as a whole. MDSAP allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit.
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In this course participants learn how to prepare fro a MDSAP audit.
On completion of this training, participants will be able to:
- Understand the fundamentals of MDSAP
- Understand what MDSAP is and why was it developed
- Gain knowledge of the regulatory authorities participate in the MDSAP program
- Understand MDSAP audit structure and core processes
- Understand the MDSAP audit cycle
- Understand how for each audit stage
- Personnel in an organization with responsibility for conducting internal audits to MDSAP requirements
- Managers and supervisory staff new to MDSAP
- Quality Engineers new to MDSAP
- Personnel with responsibility for designing and implementing medical device quality management systems