Moderator

Dr. Anuschirawan HEKMAT

Owner, Consultant to Medical Devices Industry - Regulatory Affairs & Quality Management, Dr. Hekmat CONSULTING - Project Management / Interim Management

Tübingen, Germany

Skills

Interim Management
Project Management
Beratung / Consulting
Medical Devices
Regulatory Affairs
Qualitätsmanagement
MDR
EU-Medizinprodukte Verordnung
FDA
21CFR 820 QSR
Unternehmensführung
Begeisterungsfähigkeit
Zertifizierung
aktive Medizinprodukte
passive Medizinprodukte
aktive & passive Implantate
Drug-Device Combination products
Personaltraining
Schulung
Audit
Qualifizierung
Forschung und Entwicklung
Process Validation / Prozess-Validierung
IQ / OQ / PQ
Produktleistung / Produktsicherheit
Risk Management
Verpackung
UDI
Kennzeichnung / Labeling
Biokompatibilität
Sterilisations-Validierung
EO - Ethylene Oxide
E-beam
Dampf / Steam
Gamma
Klinische Bewertung
Klinische Studien
Technische Dokumentation
Design History File (DHF)
Device History Record (DHR)
Software-Validierung
CAPA
Corrective and Preventive Actions
Medical Device Reporting
STED
Technical Documentation
Design Dossier
Reimbursement
Kostenerstattung
Orthopädie
Herzchirurgie
ISO 9000
ISO 13485
Research & Development
Requirements Engineering
Process Engineering
Systems engineering
Manufacturing engineering
R&D Engineering
Produkt- und Prozess-Engineering
Risk Engineering
Usability Engineering
Software Test Engineering
Lean Process Engineering
Engineering und Design
Clinical Study Management
Clinical Documentation
Clinical Project Management
Clinical Trial Management

Timeline

Professional experience for Anuschirawan HEKMAT

  • Current , since Jan 1994

    Consultant to Medical Devices Industry - Regulatory Affairs & Quality Management

    Dr. Hekmat CONSULTING - Project Management / Interim Management

    Project Management / Interim Management: Regulatory Affairs & Quality Management Since 1994 substantial experience in Regulatory Affairs & Quality Management of Medical Devices within the fields of Ophthalmology, Cardiology, Regional Anesthesia, Minimal Invasive Surgery, Neurostimulation, Heart Surgery, Orthopedics, Modern Wound Managment, and Diagnostics. Clinical Evaluation, as well as multicenter Clinical Studies, leading to a multitude of marketing approvals in the EU, Americas, and Asia.

  • 1 year and 1 month, Nov 2019 - Nov 2020

    Senior Consultant Medical Devices

    Osypka AG

  • 10 months, Nov 2018 - Aug 2019

    Senior Consultant Medical Devices

    Richard Wolf GmbH

  • 11 months, May 2018 - Mar 2019

    Interim Manager implanted biological Medical Devices

    non disclosed

    Design Dossier for CE mark

  • 4 months, Jan 2018 - Apr 2018

    Senior Consultant Medical Devices

    Siemens Healthineers

  • 1 month, Feb 2018 - Feb 2018

    Medical Laser Devices

    MeLysTech

  • 3 months, Oct 2017 - Dec 2017

    Senior Consultant Medical Devices

    Dornier MedTech GmbH

  • 3 months, Sep 2017 - Nov 2017

    Senior Consultant Medical Devices

    Fresenius Medical Care

  • 1 year and 3 months, Apr 2016 - Jun 2017

    Senior Consultant to Medical Devices Industry

    Paul Hartmann AG

    Project Management: Regulatory Affairs & Quality Management

  • 9 months, Feb 2016 - Oct 2016

    Senior Consultant to Medical Devices Industry

    Novartis - Alcon Grieshaber AG

    Project Management: Regulatory Affairs & Quality Management

  • 5 months, Sep 2015 - Jan 2016

    Senior Consultant to Medical Devices Industry

    Biotronik AG

    Project Management: Medical Device Combination products, Production Process Capability

  • 1 year and 8 months, May 2014 - Dec 2015

    Senior Consultant to Medical Devices Industry

    bebro electronic GmbH

    Project Management: Regulatory Affairs & Quality Management Medical Device Modules

  • 8 months, Dec 2014 - Jul 2015

    Senior Consultant to Medical Devices Industry

    Dürr Dental AG

    Project Management: Technical Documentation for Dental devices: e.g. Radiological Diagnostics, Surgical Suction, Cannulas, Compressors, Hygienic devices

  • 7 months, Jun 2014 - Dec 2014

    Senior Consultant to Medical Devices Industry

    DePuy Synthes

    Project Management: GRQP Work stream 3, CAPA-Rescue Team

  • 8 years and 2 months, Apr 2006 - May 2014

    Vice President Regulatory Affairs & Quality Management

    Retina Implant AG

    Project Management: Regulatory Affairs & Quality Management

  • 2 years and 6 months, Oct 2003 - Mar 2006

    Vice President Regulatory Affairs & Quality Management

    Pajunk GmbH

    Project Management: Regulatory Affairs & Quality Management

  • 1 year, Jan 2003 - Dec 2003

    President

    Dr. Hekmat Consulting

    Project Management: Regulatory Affairs & Quality Management Medical Devices

  • 2 years and 9 months, May 2000 - Jan 2003

    Vice President Regulatory Affairs & Quality Management

    Jostra AG - Maquet Cardio Pulmonary AG

    Project Management: Regulatory Affairs & Quality Management

  • 3 years, May 1997 - Apr 2000

    Vice President Regulatory Affairs & Quality Management

    Maquet, ortoMaquet

    Project Management: Regulatory Affairs & Quality Management

  • 2 years and 6 months, Oct 1994 - Mar 1997

    Director Regulatory Affairs & Quality Management

    Merck KGaA

    Project Management: Regulatory Affairs & Quality Management

Educational background for Anuschirawan HEKMAT

  • 3 years and 8 months, Jan 1985 - Aug 1988

    Neurobiologie

    Universität Heidelberg

  • 1980 - 1984

    Biologie

    Technische Universität Kaiserslautern

    Biomedizinische Verfahrenstechnik, Humanbiologie, Zytologie, Organische Chemie

  • 1977 - 1980

    Montana State University, USA

    Undergraduate Studies

Languages

  • German

    First language

  • English

    First language

  • French

    Intermediate

  • Italian

    Basic

  • Spanish

    Basic

  • Arabic

    Basic

  • Farsi fließend

    -

Wants

Mandate in der Medizinprodukte-Industrie
Looking for consulting opportunities within Medical Devices Industry
Interim-Management
Project Management
Technical Documentation
Design Dossier
Design Review
Risk Management
Product Development
Process Development
Clinical Trial Management
Clinical Data Management
Clinical Documentation
Clinical review
Good Clinical Practice
Packaging Management
Labelling
Corrective and Preventive Actions

Interests

Medizinprodukte zur Steigerung der Lebensqualität
Medical devices suited to improve Quality of Life
Interkulturelle Kommunikation
Inter-cultural communication
Mountain Bike
Active Fishing
Sailing

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