Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.

Product Details

SEPT has produced a checklist for the FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices May 11, 2005 document.

This is a “must have” for all quality managers and engineers involved in this FDA document. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This standard calls out or suggests over 120+ items of physical evidence. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any organization to meet the requirements of this important standard. 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 the Checklist to save time and money, it may also aid in meeting certain.

Key Words:

1. Checklist
2. FDA software standard
3. Medical devices
4. Software development
5. Software quality
6. Software Test

This product supports these Software Engineering processes

• Acquisition
• Code and Test
• Configuration Management
• Documentation
• Life cycle
• Quality
• Verification and Validation

Customers of this product:

• Airstream, LLC
• CINCI
• CYBERONICS
• Hill-Romm, Clinical Division
• Miltenyi Biotec Gmbh, Germany
• Quality validation
• Synthase USA

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.”