QMD Services has been presenting at the 3rd LISAvienna Regulatory Conference on December 3, 2019.
Anni Koubek, Raymond Nistor and Ingrid Blaimauer (all QMD Services), with Peter Halwachs Managing Director of LISAvienna and the organizer of the Regulatory Conference
Anni Koubek, CEO of QMD Services gave an overview of the Preparations for a new notified body in Austria, outlining the complexity and challenges of the ongoing notification process of QMD Services GmbH.
Ingrid Blaimauer, Head of Operations at QMD Services lead an interactive workshop on the Quality Management System requirements for MDR and IVDR
Raymond Nistor Internal Clinician at QMD Services and Nebojsa Serafimovic from the Austrian Ministry of Health presented together on the upgraded MDR and IVDR requirements on clinical investigations, clinical and performance evaluation and the Post Market Clinical Follow up (PMCF) processes.
This last presentation was followed by a moderated discussion and Q&A on Clinical Investigations, Performance Evaluation, Clinical Evaluation and PMCF, which triggered a lot of constructive and informative debate about the upcoming changes in the medical device and in vitro diagnostics regulatory framework.