Dr. Hekmat CONSULTING

Medical Devices - Regulatory Affairs & Quality Management System

Katheterlabor mit modernster Medizintechnik (Quelle: bvmed.de)
TAVI http://watchlearnlive.heart.org/CVML_Player.php?moduleSelect=replac
https://www.bvmed.de/de/bvmed/publikationen/bvmed-newsletter/bvmed-newsletter-04-16/tavi-reduziert-nicht-den-chirurgischen-klappenersatz TAVI © Edwards Lifesciences

http://www.aerztezeitung.de/medizin/krankheiten/herzkreislauf/article/898148/klappen-op-tavi-schneidet-besser-ab.html?sh=31&h=1169018965

http://www.duerrdental.com/produkte/bildgebung/duerr-dental-imaging-software/vistasoft/
http://www.duerrdental.com/produkte/absaugung/vc-45-chirurgische-saugeinheit/
http://www.synthes.com/sites/NA/Products/Trauma/PlateandScrewSystems/Pages/2.4mm_Variable_Angle_LCP_Two-Column_Volar_Distal_Radius_Plate.aspx
http://de.wikipedia.org/wiki/Herz-Lungen-Maschine
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

Consulting   & Interim Management

Quality Management & Regulatory Affairs  Medical Devices & Combination products

 

Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

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

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

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

Product & Production-process Risk Management (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.

 

 

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

 

USt-ID Nr.: DE295239280

 

Im Brühl 10/1, 72144 Dusslingen, Germany  (Stuttgart area)

Email: anusch.hekmat@gmail.com

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat

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