Dr. Hekmat CONSULTING & Interim Management
Medical Devices - Class III - Regulatory Affairs - Quality Management - Product Function & Safety - Clinical Studies - Clinical Evaluation - Technical Documentation (DHF, DMR, DHR) - Risk Management - Sterilization (EO, Gamma, E-beam, Steam) - Bioburden - Pyrogens - Biocompatibility - Packaging - Labeling (UDI) - Software - Validation (CSV) - CAPA - Audits - Supplier-Audits - Medical Imaging (CT, MRI, US, OCT) - EN ISO 13485:2016 - GMP, GCP, GLP, GDP, European Medical Devices Regulation 2017/745 MDR [MDD, AIMDD] - US-FDA 21CFR Part 820 QSR - 21CFR Part 211 - 21CFR Part 4 combination products
Anuschirawan HEKMAT, PhD
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.
Quality-Management-System Certification according to current EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
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). GMP, GCP, GLP
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.
Reimbursement schemes
Dr. Hekmat CONSULTING
www.hekmat-consulting.de https://www.hekmat-consulting.de/
Tübingen, Germany (Stuttgart area)
DUNS number 313240073
hekmat(at)hekmat-consulting.de
Mobile: +49 1708530715
secure email: A.Hekmat(at)protonmail.ch
Skype: anuschirawan.hekmat
VAT-ID / USt-ID Nr.: DE295239280
https://www.linkedin.com/in/anusch-hekmat-phd-648a9423/
https://www.xing.com/profile/Anuschirawan_HEKMAT2
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