This document summarizes the results of a 2013 survey on medical device development. It highlights top time-consuming tasks, needed improvements in visibility, and risk management as still being mostly document-centric. The document also discusses EngiSystems' software products that help with design controls, verification and validation, and compliance for medical device development.

1. The State of Medical
Device Development
Overview of Survey Results
An analysis of the 2013 Medical Device
Development survey results with insights from
industry expert, Gregory Pierce of EngiSystems

2. Survey Demographics

3. Top 10 Time-Consuming Tasks

4. Needed Visibility

5. Still Mostly Document-Centric

6. Risk Management Tools

7. Risk Management Methods

8. Risk Traceability

9. Requirements Management

10. Test Management

11. Traceability Matrix

12. Traceability Management

13. Top Issues Preventing Improvement

14. Providing Turnkey Software
Validation Solutions Since 2005
Product Software Development Lifecycle
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Design Controls Quality System Process Development
Medical Device Software Verification & Validation
Medical Device Software Development Compliance
• Class II, Class III
• Following IEC 62304
• Meeting FDA Requirements
Non-product Software
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Computerized Systems Validation
Equipment & Automated Systems Validation