KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
MDCG, MEDDEV
ISO 14971
ISO 14155
KEY CONSULTANCY SERVICES:
Training and Education
Risk Management
Regulatory Strategy
Clinical Strategy
Clinical Development Plan
Clinical Investigation Planning
Clinical Evaluation Planning and Reporting
Post-Market Strategy
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
Periodic Safety Update Reporting
Summary of Safety and (Clinical) Performance
Technical Documentation