%medical and in-vitro devices- %Augsburg-Landsberg

Dr. Astrid Hoepffner

Senior Clinical Consultant

KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
EU AIMDD 90/385/EEC
MDCG, MEDDEV, NBOG, etc.
ISO 14971
ISO 14155
Various Product Specific Standards
KEY CONSULTANCY SERVICES:
Training and Education
Communication with Notified Bodies and Authorities
Classification
Risk Management
Regulatory Strategy
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
Usefulness Reports