KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
EU Dir. 2001/83/EC Medicinal Products for Human Use
MDCG, MEDDEV, NBOG, etc.
ISO 14971
ISO 14630
ISO 10993
CTD/eCTD
KEY CONSULTANCY SERVICES:
Management
Training and Education
Communication with Notified Bodies and Authorities
Classification
Combination Devices
Risk Management
Regulatory Strategy
Biological Risk Assessment
Technical Documentation