Quality Management, Technical Documentation, Regulatory Affairs

QM:            Quality Management System, ISO 13485:2016, USA 21 CFR 820, Japan JPAL, Brazil RDC 59/2000 (BPF), Canada CMDR,
                   Sterilization validation (ISO 11135, ISO 11137), computer software validation, packaging and transport validation (ISO 11607), different process validations,
                   Change Management Implementation,
                   CAPA, Complaint handling,
                   Lead Auditor ISO 13485, ISO 9001, 21 CFR 820 for internal and worldwide supplier audits (English and German language),
                   Preparing for MDSAP for all involved countries,
                   External audit preparation and follow-up on actions,
                   Working experience with different Notified Bodies (0123, 0124, 0197, 0481, 0483)
Regulatory Affairs, Technical Documentation:
                   Medical devices class I-III, non-active and active,
                   Regulation (EU) 2017/745 MDR, 93/42/EEC MDD,
                   Preparation of Technical Files, submission and follow-up after NB inspection.
                   Worldwide registration of medical devices
                   Risk management (ISO 14971) and Usability (EN 62366-1),
                   Preparation of clinical evaluation reports,
                   Labelling, UDI, Basic-UDI-DI
                   Support submissions FDA 510(k) USA, MHLW 169 Japan, KFDA Korea, NMPA China, ANVISA Brazil.
Third party audits:
                   DEKRA Auditor EN ISO 13485:2016