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Szymon Kurdyn

Head of Notified Body (non-active medical devices)
DQS Medizinprodukte GmbH

Szymon is the appointed Head of Notified Body NB 0297 (EU MDR 2017/745, MDD 93/42/EEC) with focus on non-active medical devices.
Prior to that, he acted as certification scheme owner of ISO 13485 under CMDCAS and MDSAP, and as such is well-experienced in managing relationships with various health authorities, including Health Canada and the Standards Council of Canada, U.S. Food and Drug Administration, the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency, German national accreditation authority (DAkkS) and German Central Authority of the Länder of Health Protection (ZLG).
Over the course of the last years he actively contributed to working groups addressing various regulatory topics concerning medical devices to drive change that facilities international market access through increased transparency of regulatory frameworks and regularly gives university lectures on regulatory affairs and related topics.
He‘s a fully qualified as a body lead auditor for ISO 13485, MDSAP, MDD (MDD 93/42/EEC) and MDR (Regulation (EU) 2017/745) and routinely conducts such audits.

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