Dr. Hekmat CONSULTING   &   Interim Management

Medical Devices - Quality Management - Regulatory Affairs - Product Function & Safety - Clinical Studies / Clinical Evaluation - Technical Documentation - Risk Management - Sterilization (EO, Gamma, E-beam, Steam) - Biocompatibility - Packaging - Labeling (UDI) - Validation - CAPA - Suppliers - Audits - EN ISO 13485 - European Medical Devices Regulation MDR [MDD, AIMDD] - US-FDA 21 CFR 820 QSR - 21 CFR Part 211

Anuschirawan HEKMAT, PhD

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, Open 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 test result evaluation, Software & Hardware validation.

 

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

 

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

 

Risk Management (Risk Analysis & Risk Control) of Product & Production-process, including Additive Manufacturing (3D-printing of devices). 

 

Clinical Evaluation, Clinical Study Organization (plan & report), including effective 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) / 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), and Asia

 

Reimbursement schemes

Dr. Hekmat CONSULTING 

www.hekmat-consulting.de

 

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

 

anusch.hekmat@gmail.com

M.: +49 170 85 307 15 

Skype: anuschirawan.hekmat

 

USt-ID Nr.: DE295239280    

 

de.linkedin.com/pub/anusch-hekmat-phd/23/a94/648

https://www.xing.com/profile/Anuschirawan_HEKMAT2   

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