Description
Book SynopsisThis book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible.
By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice.
The book takes a hands-on approach by first teac
Table of Contents
1. What to Know before Getting Started, 2. ISO 13485 as the Backbone of It All, 3. IEC 62304 as The Flesh around The Bones, 4. General Requirements, 5. Software Development, 6. Software Maintenance, 7. Risk Management, 8. Configuration Management, 9. Problem Resolution, 10. Integration with Your QMS, 11. Technical Documentation, 12. Seeing into the Future, 13. Conformity Assessment, 14. Regulatory Approval, 15. Business as Usual, 16. Conclusions
