Dr. Hekmat CONSULTING & Interim Management

Medical Devices - Quality Management - Regulatory Affairs - Product Function & Safety - Clinical Studies / Clinical Evaluation - Technical Documentation (DHF, DMR, DHR) - Risk Management - Sterilization (EO, Gamma, E-beam, Steam) - Biocompatibility - Packaging - Labeling (UDI) - Software - Validation - CAPA - Suppliers - Audits - EN ISO 13485:2016 - European Medical Devices Regulation MDR [MDD, AIMDD] -  Medical Imaging (CT, MRI, US, OCT) - US-FDA  21CFR Part 820 QSR  -  21CFR Part 211  -  21CFR Part 4 combination products

Anuschirawan HEKMAT, PhD

Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for global 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 during Notified Body audits, and FDA inspections.


Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), and Asia. 


Reimbursement schemes




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



Mobile: +49 1708530715 

Phone:  +49 70728005600 

secure email: A.Hekmat@protonmail.ch 


Skype: anuschirawan.hekmat


USt-ID Nr.: DE295239280    




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