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