Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for 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, CT & NMR digital Imaging (3D), 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.
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, FDA).
Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / Project.
On site Support in Notified Body audits, and FDA inspections.
Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), and Asia
Dr. Hekmat CONSULTING
Im Brühl 10/1, 72144 Dusslingen, Germany (Stuttgart area)
M.: +49 170 85 307 15
USt-ID Nr.: DE295239280