KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
MDCG 2019-9, 2020-5, 2020-6, 2020-7, 2020-8 and 2020-13
MEDDEV 2.7/1 rev. 4
ISO 14155:2020
Various product specific standards
Dental biomaterials development and testing incl. Usability

KEY CONSULTANCY SERVICES:
Training and Education
Communication with Notified Bodies and Authorities
Classification
Clinical Strategy
Clinical Development Plan
Clinical Investigation Planning
Clinical Evaluation Planning and Reporting
Post-Market Strategy
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
Periodic Safety Update Reporting
Summary on Safety and (Clinical) Performance
Usability Testing & Reports
Literature Search Strategies
Dental biomaterials testing