The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Google
  Web Elsmar.com
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google.
PDA

View Full Version : IEC 62304 - Medical Device Software Life Cycle Processes

  1. IEC 62304:2006 Medical device software - Software life cycle processes - Issued
  2. Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software.
  3. EU Validation Requirement vs. FDA Validation Requirement - EN 62304
  4. IEC 62304 Software Development Plan
  5. IEC 62304 compliance status - Is it mandatory for 510(k) submittal?
  6. Use of FDA recognized standards: IEC 62304
  7. Risk Management for Medical Software?
  8. Evaluation of software life span - ISO 13485
  9. 93/42/EEC Class I Medical Device Weigh Scale - Class A under EN 62304?
  10. Medical Device Software - Design Outputs? ISO 90003 and ISO 62304
  11. Software Life Cycle Process Map? Template or example wanted
  12. Software Design SOP to ISO 62304 (Software life cycle for Medical Device)
  13. Software requirements and X-ray devices
  14. Software Device "Urgent" Releases? Software Change Control Process
  15. USB dongle licensing system for Medical Imaging Software
  16. IEC/TR 80002-1 Medical Device Software Part 1 has been published
  17. Is ISO 14971 certification required for IEC 62304?
  18. Requirements for using Open Source Software in Medical Devices - IVD Medical Device
  19. Software Beta Testing - Sample test plan or procedure wanted
  20. Control of the Development and Test Environment - Software for Medical Devices
  21. "value" and "over head[s]" of implementation of "CSV - validation requirements" in a