Dr. Hekmat CONSULTING & Interim Management

Medical Devices - Regulatory Affairs & Quality Management System



Katheterlabor mit modernster Medizintechnik (Quelle: bvmed.de)
https://www.bvmed.de/de/bvmed/publikationen/bvmed-newsletter/bvmed-newsletter-04-16/tavi-reduziert-nicht-den-chirurgischen-klappenersatz TAVI © Edwards Lifesciences

Source: aerztezeitung.de/medizin/krankheiten/herzkreislauf/article/898148/klappen-op-tavi-schneidet-besser-ab


Optical coherence tomography (OCT), diagnostic ophthalmology, Dr. A. Hekmat 2012


Sub-Retinal Implant (active neuro-implant), Retina Implant AG,

courtesy of Prof. Robert MacLaren, Oxford, UK


Source: Dürr Dental


Source: Dürr Dental


Source: DePuy Synthes


Source: wikipedia.org/wiki/Herz-Lungen-Maschine / heart-lung-machine


Oxigenator for open heart surgery - "Quadrox" Jostra AG
Regional Anesthesia (e.g. epidural, spinal, plexus)
Computer Assisted Surgical Planning and Robotics (CASPAR) - for orthopedics (hip, knee, spine)
Hip implant examples for CASPAR
Diagnostics - automatic analyser - Merck KG (see current technology: https://www.healthcare.siemens.com/integrated-chemistry/systems/atellica-solution-analyzers)

Interim Management & effective Consulting 

Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products


25+ years of effective Strategic & Operative expertise in Clinical & Regulatory Affairs plus Quality Management for Medical Devices industry. Market Access, within the medical fields of Arterial implants, Cardiology, open Heart & Vascular Surgery,  Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

Technical Documentation (DHF, DMR, DHR), STED,  including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.

Compliance to applicable Standards (ISO, IEC, EN, MIL).

Certifications acc. current EN ISO 13485 Quality Management Systems, 


Manufacturing Process Verification, Validation (IQ, OQ, PQ).

Product & Production-process Risk Management from Design to market  (Risk Analysis & Risk Control), including Additive Manufacturing. 

Clinical Evaluation, Organization of global multicenter Clinical Studies.

Audits of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.

On site Support in Notified Body audits, and FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.







VAT-ID / USt-ID: DE295239280

Tübingen, Germany  (Stuttgart area) 

DUNS number 313240073




secure email: A.Hekmat(at)protonmail.ch

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat


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