Medical Device Risk management Approval Made Easy

  • Make your 60601-1 3rd edition Risk Management Tables / Checklists efficiently
  • Expedite your approval submission process for Risk Management Requirements of 60601-1 3rd edition
  • Quickly create Gap List – a list of missing items in your Risk Management Files
  • 60601TurboRM Features:
    • Audits Risk Management documents for compliance with 14971 clauses related to 60601-1 3rd edition
    • Automatically identifies the most relevant documents using Document Name Search
    • Opens document, finds and highlights reference for detailed view with a single click
    • Generates Checklist, Gap Analysis, and Used Documents List
    • Provides Hints for each 60601-1 clause and ISO 14971 clause
    • Provides “Add” and “Not Applicable” check boxes for easy inclusion in Check List
    • Displays Audit Results with reference location and content overview
    • Provides easy browsing of results by 60601-1 and 14971 Clauses
    • Save and Open Project function allows to work on Check List at your own pace