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CONSULTING
- Consulting for Quality-Management-Systems according to EN ISO 9001 and/or EN ISO 13485 directives
- Consulting for Annex certificates e.g. Annex II, according to the directives MDR 2017/745/EC and for receipt of a CE-Mark with Notified Body number, too
- Conception of Technical Documentation for Medical Products for approval of a Notified Body
- EMC-Approvals for documentation of patient safety according to EN ISO 60601 directives
- Management of clinical approvals and clinical assessments according to the MDR 2017/745/EC directives and EN ISO 14971 risk Management
- Management and design of Field Studies
- Conception of expertises for medical products
- Consulting - Marketing - Logistics - Distribution
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![[ Consulting ]](cache/3a987b6882bf852262121131ab8a16f0.gif){kind=small}
