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

At Dr. Hekmat Consulting, my focus is on steering innovative medical devices through the complex terrain of global regulatory affairs and quality management. With a strong grasp of the European, American, and Asian markets, my strategic and operative expertise propels medical technology from conception to widespread clinical use.

Our team’s accomplishments include successful multicenter clinical studies and securing numerous marketing approvals. Mastery in regulatory affairs, coupled with a deep understanding of class III medical devices, ensures that clients receive unparalleled guidance navigating the stringent requirements of international medical device regulations.

30 years of effective Strategic & Operative expertise in Regulatory Affairs & Quality Management for Medical Devices industry global 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,

pharmaceutical inspections acc. GMP,

Manufacturing Process Verification and Validation (DQ, IQ, OQ, PQ).

Risk Management (Risk Analysis & Risk Control) of Product & Production-process, including Artificial Intelligence, Additive Manufacturing (3D-printing).

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

Consumer products, International Featured Standard IFS-HPC v3, FSC, RSPO

Dr. Hekmat CONSULTING

www.hekmat-consulting.de https://www.hekmat-consulting.de/

Tübingen, Germany (Stuttgart area)

DUNS number 313240073