Events

Medical Device Single Audit Program @ Vienna

Friday December 02th
Vienna, if a face-to-face seminar is not possible, it will take place online

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 group
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

Medical Device Single Audit Program @ Vienna

seminar content

  • The basics of the MDSAP audit model and accompanying guidance
  • Structure and scope of the MDSAP
  • the audit processes and their interrelationships
  • Practical exercises for formulating deviations and classifying nonconformities according to the MDSAP model
  • How to effectively prepare for an MDSAP audit
  • incl. seminar documents as PDF and certificate of participation

Costs for members of LISA

LISA members are the communities of Ecoplus, Human.technology Styria, LISAvienna and Life Sciences Tirol

290  per seminar

646,- for all 3 Seminars (14.10., 4.11., 2.12.)

all information excl. VAT

Cost without membership

€ 440, - early bird (up to 4 weeks before)

€ 490 standard (4 to 2 weeks before)

€ 520,- last minute (less than 2 weeks before)

incl. seminar documents as PDF and certificate of participation

€ 1.190 package for all 3 seminars:

all information excl. VAT

Any questions?

Then simply contact:

Lorenz Neuhauser

+43 699 188 99 706

lorenz.neuhaeuser@human.technology.at  

Other Partners

This event takes place in cooperation with en.co.tec Schmid KG, Ecoplus, Human.technology Styria, LISAvienna and Life Sciences Tirol.

The event is co-financed by LISA Life Science Austria.

Further seminars on our USA focus:

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