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 Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"

The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document” Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005 This checklist reflects these new requirements. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The Checklist clarifies what is required for compliance through a product evidence list that will assist any software organization in meeting the requirements of this guideline. Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase. Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements. A quality product at a reasonable price!

This product supports these Software Engineering processes

• Configuration Management
• Design
• Documentation
• Integration
• Life Cycle
• Quality
• Safety
• Security
• Verification And Validation

Customers of this product:

• Minerva Surgical
• Olympus software technology, Japan
• SCC Soft Computer
• Uptake Medical

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”