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) - Bioburden - Pyrogens - Biocompatibility - Packaging - Labeling (UDI) - Software - Validation (CSV) - CAPA - Audits - Supplier-Audits - Medical Imaging (CT, MRI, US, OCT) - EN ISO 13485:2016 - European Medical Devices Regulation 2017/745 MDR [MDD, AIMDD] - US-FDA  21CFR Part 820 QSR  -  21CFR Part 211  -  21CFR Part 4 combination products

Anuschirawan HEKMAT, PhD

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

 

Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory tests, Software & Hardware validation (CSV, ERP), Preclinical & Clinical evaluation, Post Marketing Surveillance (PMS), Post Market Clinical Follow-up (PMCF).

 

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), Ethics Committees (IRB), including effective global multicenter Clinical Studies.

 

Audits & Evaluation of Production Processes & Suppliers.

 

Medical Device Reporting to Competent Authorities (e.g. BfArM, US-FDA).

 

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / Corrective Project.

 

On site Support during Notified Body audits (e.g. TÜV), and US-FDA inspections.

 

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

 

Reimbursement schemes

Dr. Hekmat CONSULTING 

www.hekmat-consulting.de

Germany  (Stuttgart area)

 

 

anusch.hekmat(at)gmail.com

hekmat(at)hekmat-consulting.de

Mobile: +49 1708530715 

 

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

 

Skype: anuschirawan.hekmat

 

VAT-ID / USt-ID Nr.: DE295239280    

 

https://www.linkedin.com/in/anusch-hekmat-phd-648a9423/

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

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