Dr. Hekmat CONSULTING

 

Active Neuro-Implant for Ophthalmology

 

Schematics of sub-retinal implant, courtesy of Oxford eye hospital 2013-02-04

 

 

Medical diagnostic imaging

 

OCT - Dr. A. Hekmat 2012-06

Spectral Domain Optical Coherence Tomography (SD-OCT)

http://www.heidelbergengineering.com/international/products/spectralis/technology/spectral-domain-oct/

 

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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