Unser Team

Wir freuen uns auf den Austausch mit Ihnen.

Frank Ruben

Managing Director

        

Alexander Maier

Managing Director

        

Bernd Hoffmeister

Chief Financial Officer

        



Sales



Marcel Bursch

Sales Manager

        

Tel.: +49 3378 20 55 180
Mobil: +49 151 108 65 385

Florian Praeker

Sales Manager

        

Tel.: +49 3378 20 53 264
Mobil: +49 151 730 132 04

Kompetenzfelder im Überblick


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, 10992, 15223. Usability, Medical Devices, GLP, GSP, GDP (documentation) PMS, PMCF, PMPF, e.g. incidents, MAUDE, PUBMED, etc. Certification Process: Preclinical development, regulatory strategies Project Management, QMS, internal Audits, Notified Bodies, Competent Authorities, IRBs/Ethics Committees, DMIDS 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 MPDG §83 Validierungen & Qualifizierungen, Nahrungsergänzungsmittel, Novel Food IATF 16949, ISO 14001, 14155, 15224, 50001, 9100, usw. Zulassungsprozess: Klinische Entwicklung, Training & (Inhouse/remote) Seminare, Workshops, ESG Legal Framework, EU Green Deal, CSRD, SFDR, EU-Taxonomie, Software, GAP-Analysen