FDA Compliance, 510(k), Premarket Approval (PMA) Human Factors Studies, CSP, CSR FDA 21 CFR Part 820 ISO standards, e.g. 9001, 13485, 19011, 60601, 62366. Usability, Medical Devices, GLP, GSP, GDP (documentation) PMS, PMCF, e.g. incidents, MAUDE, PUBMED, etc. Certification Process: Preclinical development, regulatory strategies Project Management, QMS, internal Audits, Notified Bodies, Competent Authorities, IRBs/Ethics Committees, DIMDI MDR, Clinical Evaluations of Medical Devices, MEDDEV 2.7/1 Rev 4 Risk Management, FMEA IVDR, Performance Evaluations, Market Survey & Analyses FDA 21 CRF Part 11, ISO standards, e.g. 17025, 27001, 62304 etc. Market Authorisation Process: Product registration, CE Compliance, UDI, Literature & databases searches DHF, DHR, DMR, Technical Documentation, Inspektionen & Audits, z.B. FDA, Brasil, Russland, MDSAP Klinische Studien, ICH GCP, GMP, GxP , Reinraum & Sterilisation Strahlenschutz, Datenschutz, Arbeitssicherheit, QMB, Medical Writing, Medizinprodukteberater §31 MPG Validierungen & Qualifizierungen, Nahrungsergänzungsmittel, Novel Food IATF 16949, ISO 14001, 14155, 15224, 50001, 9100, usw. Zulassungsprozess: Klinische Entwicklung, Training & Seminare