KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
MDCG, MEDDEV, NBOG, etc.
ISO 14155
ISO 13485
ISO 9001
KEY CONSULTANCY SERVICES:
Clinical Quality Management System
Clinical Aspects in EU Regulatory and Normative Framework
QM System Auditing
Clinical Audits
Supplier Audits for Clinical Services Providers
Clinical Evaluation Processes
Literature Search Approaches
Reporting Obligation
Post-Market Surveillance Systems
Post-Market Clinical Follow-up System
Summary on Safety and Clinical Performance
Periodic Safety Update Reporting
Promotional Material
Training and Education