How we can help you to ensure your compliance with all European regulations?
Our consulting services for MD (Medical Devices) and IVD (In Vitro Diagnostic Medical Devices) compagnie:
- Regulatory Affairs
- Technical File Compilation
- Medical Device Certification
- Registration Services
- Clinical Evaluation Reports (CER)
- ISO 13485 – 17025 Implementation
- Validation Services
- Audit Services
We also offer In-depth Feasibility Studies, Market Entry Strategy, Risk Management and Usability Engineering, Organisation of Clinical Trials in Italian Hospital Facilities and the new Classification of the Medical Device.