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.)

Product/Process Requirements

• Software Validation (ISO 62304)
• Risk Management according to UNI CEI ISO 14971:2002 standard (Application of Risk Management to Medical Devices).
• Clinical Studies Verification

Training

• Basic Training & Tailored Courses