Key Competence and Experience:
EU MDR 2017/745
EU AIMDD 90/385/EEC
MDCG and NBOG guidance documents
MEDDEV 2.7/1 Rev. 4, etc.
KEY CONSULTANCY SERVICES:
Communication with Notified Bodies and Authorities
Device Classification
Promotional Material
Technical Documentation Review
Summary of Safety and Clinical Performance
Literature Search Strategies
Change Assessment
EU Clinical Evaluation Plan and Report
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan