Description: Ich bin Anuschirawan Hekmat aus Dußlingen und erzähle euch auf dieser Webseite ein paar Geschichten aus meinem Leben.
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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).