I do have extensive knowledge of Quality Management (EN ISO 13485, ISO 9001, 21CFR Part 820, 21CFR Part 211, cGMP, GCP, 21CFR Part 4) and Regulatory Affairs (Europe, Americas, Asia). European Medical Devices Regulation (MDR). Medical Device Performance, Safety, Clinical effectiveness & usability.
As Vice President Quality Management & Regulatory Affairs, I have been working in various global medical devices companies.
Strategic and hands-on work experience include:
Quality-Management-System Certification according to current EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
Management of internal and external suppliers, such as required for R&D, additive manufacturing, coating, biocompatibility, mechanical & electrical testing, labeling (UDI), packaging, and sterilization.
Structuring, completion, and reorganization of Technical Files to fit global requirements have been and still are within my main focus. Such work experience includes, but is not limited to, Risk Management (EN ISO 14971, EN ISO 12100), Validation of EO-, radiation-, and steam-sterilization (EN 556, EN ISO 11135 & 11137), Clinical Evaluation (EN ISO 14155), physical-mechanical testing (EN IEC 60601), software validation (EN ISO 62304) and Biocompatibility testing (EN ISO 10993). Validation of product & production processes (DQ, IQ, OQ, PQ), including Enterprise Resource Planning (ERP) and stand-alone medical device software.
Process capability evaluation of drug-device combination products (e.g. drug release kinetics, content, purity, and surface coating condition).
Post market surveillance activities include effective management of customer complaints, Corrective And Preventive Action (CAPA) including non-conformities (NC), medical device reports (MDR) and medical device vigilance reports (MDV) to competent authorities (e.g. US-FDA, BfArM), as well as post market clinical follow-up to obtain long-term safety & function data on medical devices form participating patients.
Reimbursement for medical devices leading to return of investments.
Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products
25+ years of effective Strategic & Operative expertise in Clinical & Regulatory Affairs plus Quality Management for Medical Devices industry. Market Access, within the medical fields of Arterial implants, Cardiology, open Heart & Vascular Surgery, Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D), and in vitro Diagnostics.
Technical Documentation (DHF, DMR, DHR), STED, including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.
Compliance to applicable Standards (ISO, IEC, EN, MIL).
Certifications acc. current EN ISO 13485 Quality Management Systems,
GMP, GCP, GLP, GDP,
Manufacturing Process Verification, Validation (IQ, OQ, PQ).
Product & Production-process Risk Management from Design to market (Risk Analysis & Risk Control), including Additive Manufacturing.
Clinical Evaluation, Organization of 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) / corrective 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), & Asia, including Reimbursement schemes.
Dr. Hekmat CONSULTING
VAT-ID / USt-ID: DE295239280
Tübingen, Germany (Stuttgart area)
DUNS number 313240073
secure email: A.Hekmat(at)protonmail.ch
Mobile: +49 170 8530715