Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) audit model was developed on the initiative of the International Medical Device Regulators Forum (IMDRF). The MDSAP describes a standardized procedure for quality management audits of medical device manufacturers. Australia, Brazil, Canada, Japan and the USA are involved in the MDSAP audit model.
In this seminar you will learn how to interpret the audit model correctly and know which aspects manufacturers need to consider in order to successfully prepare for an MDSAP audit.
The seminar contents
- The basics of the MDSAP audit model and the associated guidelines
- Structure and scope of the MDSAP, the audit processes and their interrelationships
- Practical exercises for formulating deviations and classifying non-conformities according to the
- MDSAP model
- How to prepare effectively for an MDSAP audit.
Costs
1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.
your trainer
Mag. Thomas van den Oever, independent service provider with around 20 years of experience in the field of medical technology. Consulting focus on QMS optimization, training and auditing (ISO 9001:2015, ISO 13485:2016, MDR, IVDR, MDSAP), including auditor at TÜV Süd;
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
