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About This Item
Save 50% off the list prices when ordering this collection of medical device standard checklists!
This kit includes:
- FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - Evidence Product Checklist
- General Principles of Software Validation - Final Guidance for Industry and FDA staff - Evidence Product Checklist
- Checklist for the FDA Document Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices As Amended by Guidance for Industry, FDA Reviewers and Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software
- Checklist for ISO/IEC 90003
- Checklist for ISO 9001
- Checklist for UL 1998
- Checklist for IEC 60601-1-4
- Checklist for IEC 62304
- Checklist for ANSI/AAMI/ISO Standard 13485:2003
- New! Checklist for ISO 9001:2008
This kit comes with four hours of free consultation. SEPT will answer any question concerning the standards or checklists for 60 days after purchase.