KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU IVDR 2017/746
EU CTR 536/2014
EU MDD 93/42/EEC
EU AIMDD 90/385/EEC
MDCG, MEDDEV and NBOG Guidance Documents
ISO 14155, ISO/TR 20416 / Good Clinical Practice (GCP)
ISO 13485
ISO 14971, ISO/TR 24971
ISO 10993
U.S. Medical Device Regulation
Common Specifications
Guidelines by Orthopedic Expert Societies
KEY CONSULTANCY SERVICES:
Management and Leadership
Training and Education
Clinical Audit and Assessment
Communication with Notified Bodies, Authorities and Key Opinion Leaders
Clinical Expertise for Risk Management
Clinical and Regulatory Strategy
Clinical Investigation Planning and Reporting
Post-Market Strategy and Real World Evidence
EU Clinical Evaluation Planning and Reporting
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
Periodic Safety Update Report
Summary on Safety and Clinical Performance