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