MDSAP has been in place since 2015. In 2020 we will see the growth of the MDSAP Affiliate program and the implementation of MDR for manufacturers. It is time to see how these programs can become more harmonized for the ease of the manufacturers and auditors in implementation, review and assessment of the implemented quality management systems. Agreement and acceptance on a design file format and grading of non-conformances are just two of these areas. Many more can be explored with the panel. Experiences will also be shared by regulators, consultants, assessors and manufacturers in their journey to implement these programs.
Learning Objectives:
Define the way multiple medical device schemes are harmonized and can become harmonized.
Describe the techniques for the harmonization of activities within their company.
Challenge the efforts of harmonization improvements.
