Dr. Hekmat CONSULTING & Interim Management



Active Neuro-Implant for Ophthalmology

for partial restoration of vision of the totally blind


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


Medical diagnostic imaging



OCT      Optical Coherence Tomography


OCT - Dr. A. Hekmat 2012-06

Spectral Domain Optical Coherence Tomography (SD-OCT)


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



X-ray imaging  

via C-arm for targeting of renal stones and lithotripsy

Source:   https://www.dornier.com/products/ 



MRI       Magnetic Resonance Imaging / Angiography




Contact us to evaluate / validate your Imaging process.





Consulting   & Interim Management

Quality Management & Regulatory Affairs  Medical Devices & Combination products


Since 1994, effective Strategic & Operative expertise in Quality Management & Regulatory Affairs for Medical Devices industry Market Access, within the fields of Arterial implants, Heart & Vascular Surgery, Cardiology, 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) 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.






VAT-ID / USt-ID: DE295239280

Tübingen, Germany  (Stuttgart area)




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

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat



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