KEY COMPETENCE AND EXPERIENCE:
ISO 13485
ISO 14971
ISO 15223-1
ISO 20417
ISO 10993-1
IEC 62366-1
EU MDR 2017/745
MDCG
KEY CONSULTANCY SERVICES:
Audit
Document system Management (Process,
Procedures, etc…)
KPI Monitoring
Risk Management
CAPA and Root Cause Analysis
Technical Documentation
Regulatory Strategy
Quality and Regulatory culture
Scrum Methodology
Literature Search Support