25+ years of effective Strategic & Operative expertise in Regulatory Affairs & Quality Management for global Medical Devices industry Market Access, 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, Class III medical devices, and in vitro Diagnostics.
Technical Documentation (eCTD, DHF, DMR, DHR, STED) 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)
DUNS number 313240073
Mobile: +49 1708530715
secure email: A.Hekmat(at)protonmail.ch
VAT-ID / USt-ID Nr.: DE295239280