KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU IVDR 2017/746
EU PPE 2016/425
EU MDD 93/42/EEC
EU AIMDD 90/385/EEC
MDCG, MEDDEV, NBOG, etc.
ISO 13485
ISO 14971, ISO/TR 24971
ISO 14630
ISO 10993
ISO 14155, ISO/TR 20416
Various Product Specific Standards such as ISO 5840, IS0 5910
Common Specifications such as the one on Annex XVI Devices
KEY CONSULTANCY SERVICES:
Management and Leadership
Training and Education
Audit and Assessment
Communication with Notified Bodies and Authorities
Promotional Material
Risk Management
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