Medical DevicesCertification and Regulatory Compliance

Product regulations and associated documentation to be addressed as part of product design and manufacturing for marketing and sale of the product across the globe, including safety and reliability testing for the product usage and country-specific regulations, addressing necessary quality system requirements towards this.

  • Quality Engineering

    • Supplier Vendor Programs
    • CAPA
    • Control Implementation support
    • DFMEA, PFMEA
    • Support Services
    • SOP development & compliance support
    • ISO 13485,MDD/93/42/EEC compliance support
    • Training Program Implementation support
  • Technical Support and Review

    • Engineering Reports
    • Design and Manufacturing Records
    • Quality Control Records
    • Design and Development Planning
    • Design Verification and Validation
    • DHF and DMR Support
    • Process Validation
    • Risk Management as per ISO 14971
  • Regulatory Affairs

    • Design Dossiers/Technical File
    • DHF and DMR Gap Analysis
    • QSR Subsystems Compliance Support
    • 510(k) Submission, CE Marking
    • QSR-GMP GAP Analysis
    • Mock Inspection Audits
    • Medical Device Products Registration with Regulatory Agencies
  • IEC 60601-1-3 & ISO 14971 Compliance

    • FDA
    • UL
    • ISO
    • CE (EU MDD)
    • IEC
    • AAMI

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