Based on more than 25 years of work experience with a Notified Body, in Quality Management & Regulatory Affairs of medical devices (MD) and in-vitro diagnostics (IVD) as well as in Technical Documentation and Research & Development I offer competent and reliable support especially in the following areas:

• Market Access in US (510(k) and DeNovo), China, Canada + …
• MDR/IVDR compliance
• Technical Documentation (e.g. adaptation to MDR requirements)
• Quality Management acc. to ISO 13485:2016
• Risk Analysis acc. to 14971 as well as special standards
• Clinical Evaluation(MD)/Performance Evaluation (IVD) and Investigations
• Usability acc. to the harmonized standard EN 62366
• Biocompatibility acc. to ISO 10993-1 to 20 + special standards
• UDI (Unique Device Identification)
• Post-Market Surveillance
• MDSAP (since Jan. 1, 2019 required for Canada)
• Auditing according to MDD and ISO 13485:2016 and MDR

Work Experience e.g.

• ECM, Notified Body 0481: Deputy Techn. Director
• Lohmann & Rauscher GmbH & Co. KG: Regulatory Affairs Manager
• Bruker Daltonik GmbH: Regulatory Affairs Manager
• Chromsystems GmbH: Head of QM/RA + QMR
• Dionex Corporation: Project Manager Technical Documentation
• Roche Diagnostics/Boehringer Mannheim: Developer
• and other leading positions in QM/RA of medical device manufacturers

Product Areas (examples)

• modern wound care
• bandages and orthoses
• ventilation and inhalation systems
• endoscopic spinal surgery products incl. implants
• dental products incl. 3D printing
• diagnostics of micro organisms
• therapeutic drug diagnostics
• diagnostics of vitamins

Product Categories

• hardware devices and systems
• software
• chemical reagents
• biological products
• textiles
• metal alloys, ceramics and synthetics