Quality Management & Regulatory Affairs Medical Devices & Combination
products
Since 1994, effective Strategic & Operative
expertise in Quality Management & Regulatory Affairs for Medical Devices industry Market Access, within the fields of Arterial implants, Heart & Vascular Surgery, Cardiology,
Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D),
andin
vitroDiagnostics.
Technical Documentation (DHF, DMR, DHR) including
Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.
Compliance to applicable Standards (ISO, IEC, EN,
MIL).
Manufacturing Process Verification, Validation (IQ,
OQ, PQ).