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Medical Devices

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‚Äôs 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