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.
Dr. Hekmat CONSULTING
Germany (Stuttgart area)
Mobile: +49 1708530715
secure email: A.Hekmat(at)protonmail.ch
VAT-ID / USt-ID Nr.: DE295239280