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  • Quality System Support
  • ISO 13485 Auditing Service
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  • MDSAP – Medical Device Single Audit Program
  • SOP – IOP
  • VMP IQ/OQ/PQ Validation
  • Clean Room Design and Validation

  • MDR Consulting Service
  • EU Authorized Representative Service
  • CH-REP – SAR Swiss Authorized Representative service
  • EU PRRC
  • Design Control Process
  • DHF Design History File
  • Technical File Design Dossier
  • Risk Management Process
  • Clinical Evaluation
  • ISO 14971:2012 – 2019 Gap Analysis

Meet us at

  • Mechanical Test Fatigue Static
  • Biological Safety Evaluation
  • Cardiovascular Digital Simulation Model
  • ISO 10993-17 Toxicological Evaluation
  • Test Mascherine Chirurgiche e FFP2, FFP3 – Coronavirus

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