Workshop to take advantage of ISO 13485 to explore the MDSAP world

MDSAP (Medical Device Single Audit Program) is an audit program initiated by several regulatory authorities to standardize the requirements for a quality management system in the medical device industry as part of the approval process of medical devices and to provide a consistent procedure for performing system audits at the medical device manufacturer.
MDSAP is recognized by several countries and can facilitate the market access to these countries for medical device manufacturer by reducing the amount of system audits through regulatory authorities.

In preparation for MDSAP, the medical device manufacturers has to handle the challenge of implementing a quality management system that complies completely with the country-specific requirements for a quality management system while being applicable and effective for the company. It is advisable to implement standardized and streamlined processes in the quality management system in order to gain a competitive advantage over other medical device manufacturers in the market.

Your benefit

The training offers you the opportunity get to know the audit program "MDSAP" and regulatory pathways for the standardized and streamlined implementation of the different country-specific requirements into your existing quality management system.


  • What is the MDSAP program?
  • How are auditing organization conduct MDSAP audits?
  • Get familar with the different country-specific regulations with focus on quality management system requirements of the MDSAP countries
  • Similarities and differences between the country-specific QMS regulations of the MDSAP countries
  • Process map / relevant processes
  • Get possible implementation strategies to comply with the MDSAP requirements
Target audience: 
The course is adressed to participants from the fields of regulatory affairs and quality management of medical device manufacturers.
German and English, cf. Date
Language of training material: