Volker Sudmann
Head of Branch Office austria, Auditor, Expert
mdc medical device certification GmbH
Vienna, Austria
3 profile visitsSpeakerSpeaker
My organisation
mdc medical device certification GmbH
mdc medical device certification GmbH
Notified body
Vienna, Austria
The name mdc medical device certification stands for quality and safety in the sensitive field of medical devices and healthcare.
More than 115 employees as well as 70 external auditors and technical experts currently contribute to this. They ensure that we, as a Notified Body in the field of medical devices and in vitro diagnostics as well as an accredited certification body for QM systems, are one of the leading providers not only in Austria and Germany but also in Europe. The comprehensive expertise of our employees enables us to offer certifications for a wide range of products and services as well as for companies of all sizes.
More than 2,000 customers in over 30 countries trust our knowledge and our service. Their customers and contractual partners also rely on our certificates and the products that bear the CE mark in conjunction with our identification number “0483”.
Through our work, we not only make an important contribution to the safety of patients and users of medical devices, but also promote quality in the economy.
In addition to our expertise, the cornerstones of our work are independence, objectivity, neutrality, and confidentiality. With offoces in Vienna, Stuttgart, Berlin, Tuttlingen, and Haifa, we are a competent partner both nationally and internationally.
Speaker sessions (1)
Wednesday, 15 October 2025
15:15 - 16:30
C2: Post market surveillance and periodic safety update report (PSUR)
Location:Room 5: Franz Joseph
- Volker Sudmann: Looking beyond the horizon – what matters regarding PSUR
- Viktoria Knoflach: Post-Market Surveillance requirements and submission of PSURs for class III / Implantable devices
- Birgit Sebauer: PMS and its requirements in countries beyond Europe