Regulatory Affairs & Quality Management, Class III Medical Devices & Combination
products
30 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), andin
vitroDiagnostics.
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 Artificial Intelligence, & 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).