KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU IVDR 2017/746
EU MDD 93/42/EEC
EU AIMDD 90/385/EEC
MDCG, MEDDEV, NBOG, etc.
ISO 13485
ISO 14971, ISO/TR 24971
ISO 10993
ISO 14155, ISO/TR 20416
IEC 60601
IEC 62366
Various Product Specific Standards
KEY CONSULTANCY SERVICES:
Training and Education
Communication with Notified Bodies
Risk Management
Regulatory Strategy
Clinical Strategy
Post-Market Strategy
Technical Documentation Writing
Clinical Investigation Planning and Reporting
Clinical Evaluation Planning and Reporting
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
Summary of Safety and Clinical Performance