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] - European Authorised Representative - 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 Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Open Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, Imaging (CT, NMR, OCT), 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 (CSV, ERP).

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, US-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 (e.g. US-FDA), and Asia.

Reimbursement schemes

Dr. Hekmat CONSULTING

www.hekmat-consulting.de