Medical Devices - Voisin Consulting

Medical Devices

Voisin Consulting Life Sciences assists biomedical and medical technology companies in determining the appropriate regulatory strategy based on the product and its environment.

Design and implementation of innovative and global development plans
Preparation, submission and follow-up of regulatory filings to Competent Authorities
Comprehensive recommendations for the development of innovative medical devices

Regulatory strategy and product development
Quality system support (ISO 13485, FDA SQR, CMDCAS, etc.)
Design controls and risk management plans (ISO 14971)
Nonclinical support, including GLP assessments
Clinical strategy and clinical development plans
EU Notified Body selection and interaction
Regulatory submissions and product registration (CE Mark, 510k, PMA, IDE, etc.)
HUD applications
Supplier Quality Assessments
Warning letters and recalls
Medical Device vigilance systems
US Agent (FDA)

Cambridge • Lausanne • Paris/Rennes • Bangalore • Singapore • London