Bernd Priessnitz

Inhaber, Medical Device Technology & RA/QA Consultant, ViARATiO CONSULTiNG, Murr (Germany)
Murr, Deutschland

Fähigkeiten und Kenntnisse

Biomaterials
Implants
Medical Products
IVD´s
Quality management
Regulatory Affairs
Project management
R&D
Audits
Training

Werdegang

Berufserfahrung von Bernd Priessnitz

  • Bis heute 22 Jahre und 7 Monate, seit 2003

    Medical Device Technology & RA/QA Consultant

    ViARATiO CONSULTiNG, Murr (Germany)

    Consulting focus on medical devices, IVD´s, biotechnology for tissue engineering and (bio)pharmaceutical technology (incl. clean room production, packaging and sterilisation), hygiene management / External expert and auditor for medical devices acc. MDD, MDR (EU), IVDR (EU), EN ISO 13485, EN ISO 9001, EN ISO 17025 etc. & US QSR acc. 21 CFR 820 / Complaint management, root cause analysis, FMEA, CAPA processes / RA & QA consulting incl. of combination ("borderline") products

  • 1997 - 2002

    Chief Executive Officer (CEO)

    OSSACUR AG, Oberstenfeld & Tübingen (Germany)

    Biotechnology based medical devices for surgical orthopedics, dentistry & CMF osteosynthesis / Surface-modified resorbable biomaterials for the human in-situ tissue engineering (incl. bioceramics, collagen, bone & cartilage morphogenic proteins and antibiotics

  • 1995 - 1997

    Vice President R&D Biomaterials

    Pfizer / Howmedica Leibinger GmbH, Freiburg i. B. (Germany) & Dallas (USA)

    Biomaterials (resorbable bioceramics, bone cements, biopolymers etc.) and implants (stainless steel, titanium alloys etc.) for osteosynthesis and CMF surgery / Surface coatings of titanium implants, packaging and sterilization technologies

  • 1990 - 1994

    Scientific Assisstant Biomaterials Research

    Julius-Maximilians-University Würzburg (Germany)

    Surface modification and PVD plasma coating technology for medical implants / Biomechanical, electrochemical and physical medical device testing / Interface reactions of biomaterials in the biological environment

  • 1985 - 1989

    Department Manager Galenics & Pharmaceutical Technology

    Pfrimmer Kabi GmbH & Co. KG, Erlangen (Germany)

    Technology of oxygen sensitive drugs in liquid application forms and shelf life testing (incl. prevention of Maillard reactions in multi-component formulations) / Research in the field of new perfluorcarbon based blood substitutes / Packaging, HTST & microwave sterilization technology of parenteral medicinal products

Sprachen

  • Deutsch

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  • Englisch

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