Medical Device Single Audit Program @ Vienna

The Medical Device Single Audit Program (MDSAP) audit model was developed at the initiative of the International Medical Device Regulators Forum (IMDRF). The MDSAP describes a uniform procedure for quality management audits by 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 correctly interpret the audit model and know which aspects the manufacturer must consider in order to successfully prepare for an MDSAP audit.

target audience
This seminar is suitable for medical device manufacturers and exporters, decision-makers who are considering participating in the MDSAP program and people who have been commissioned to prepare their company for an audit according to MDSAP, as well as external and internal auditors.

Basic knowledge of ISO 13485:2016 – quality management for medical devices and IVD is required.

Trainer
Mag. Thomas van den Oever, independent service provider with around 20 years of experience in the field of medical technology. Consulting focus QMS optimization, training and auditing (ISO 9001:2015, ISO 13485:2016, MDR, IVDR, MDSAP) including auditor at TÜV Süd