KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
MDCG, MEDDEV, NBOG, etc.
ISO 13485
ISO 14971
ISO 10993
ISO 14155, ISO/TR 20416
ISO 20417
Product Specific Standards and Guidlines

KEY CONSULTANCY SERVICES:
Training and Education
Communication with Notified Bodies and Competent Authorities
Assisting in the consoltation procedure for Medical Devices Containing Ancillary Medicinal
Substances
Regulatory Strategy
Clinical Strategy
Post-Market Strategy
Technical Documentation Writing and Review
Clinical Investigation Planning and Reporting
Clinical Evaluation Planning and Reporting
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
Complaint Handling and Recalls
Change Managment
Summary of Safety and Clinical Performance
Scientific Publication