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With the introduction of the Medical Device Single Audit Program (MDSAP) in 2016, another module for audits and possibly a new auditing organization as a controller for the quality management system was added. The group of MDSAP countries currently consists of the USA, Canada, Australia, Japan and Brazil. MDSAP certification has been mandatory for market approval in Canada since 2019. Other countries join the program as affiliate members.
The seminar helps to better understand MDSAP in order to be able to prepare for the upcoming audits or document reviews.
topic overview
- Background and fundamentals of the MDSAP program
- Structure and process of the MDSAP certification
- Classification and impact of the deviations
- Calculation of the audit duration
- Structure and division of the chapters
- Country-Specific Requirements
- Preparation for the MDSAP audit
target group
Quality Management or Regulatory Affairs employees of manufacturers who sell or intend to sell in the United States, Canada, Australia, Brazil or Japan.
previous knowledge
Initial experience or knowledge of quality management systems according to DIN EN ISO 13485 desirable, but not mandatory.
KONTAKT:
Online
