U.S. Market Introduction
- Assistance in FDA registration requirements (establishment, listing, etc.).
- Support in preparing a Premarket Notification (510k).
- U.S. Agent Service
Company Quality Management
- Company Quality System assessment in respect of GMP and ISO requirements.
- Company Quality System assessment/building-up according to 21 CFR 820 requirements.
- Assistance in building-up (or upgrading from ISO 9001:94) a Company Quality System according to ISO 13485:2003.
- GMP/ISO Company Quality System Management/Maintenance
- Support in building and managing an harmonised Company Quality System compliant to different regulatory systems (ISO, GMP, etc.)
- Assistance during Authority’s Inspections (FDA, Certification Notified Bodies, etc.)
- Software Validation (ISO 62304)
- Risk Management according to UNI CEI ISO 14971:2002 standard (Application of Risk Management to Medical Devices).
- Clinical Studies Verification
- Basic Training & Tailored Courses