KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU IVDR 2017/746
EU MDD 93/42/EEC
EU AIMDD 90/385/EEC
MDCG & MEDDEV
ISO 13485
ISO 14971, ISO/TR 24971
ISO 10993
ISO 14155, ISO/TR 20416
U.S. Medical Device Regulation
Canadian CMDR (SOR/98-282)
KEY CONSULTANCY SERVICES:
Regulatory Strategy
Clinical Strategy
Post-Market Strategy
Technical Documentation Writing
Clinical Development Plan
Clinical Investigation Planning and Reporting
EU Clinical Evaluation Planning and Reporting
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
Summary on Safety and (Clinical) Performance
Training and Education
510(k) Preparation
Canadian Medical Device Licensing