KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
EU AIMDD 90/385/EEC
ISO 13485
ISO 14971, ISO/TR 24971
Various Product Specific Standards such as ISO 5840, IS0 45502-2-3
KEY CONSULTANCY SERVICES:
Design Control
Technical Documentation Writing
Quality Management System
Risk Management
Training and Education