Services

    • Right size QMS Implementation

    • Create gap assessment and action plan

    • Implement into quality system

    • Find the issue

    • Fix the issue

    • ISO 13485

    • FDA 820

    • MSDAP

    • Requirements

    • Hardware, Software, and System Verification and Validation

    • Standard Testing (60601, bio-comp, packaging, usability, etc.)

    • 501(k)

    • Technical File

    • Adhoc testing

    • Write and execute Verification

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