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The Key to Continuous Compliance for Medical Device Software Developers

Risk is not an option in medical device software development. So, you need to mitigate time-to-market, FDA, and security risks. Or you could be facing a costly recall or software update.

Modern software developers use continuous testing to detect these defects and resolve them faster. This reduces risk, improves developer productivity, and lowers product development costs.

Similarly, medical device software developers can use static analysis for continuous compliance. This reduces security defects, improves workflows, and accelerates time-to-market.

In this presentation, you’ll learn how to use static analysis to:
- Ensure continuous compliance with industry standards and regulatory requirements.
- Improve security for increasingly connected medical devices.
- Enforce corporate and industry coding rules and best practices.
- You’ll also learn why the Klocwork static analysis solution is ideal for medical device developers.

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The Key to Continuous Compliance for Medical Device Software Developers

  1. 1. The Key to Continuous Compliance for Medical Device Software Developers WALTER CAPITANI, DIRECTOR, PRODUCT MANAGEMENT, KLOCWORK | APRIL 4, 2019
  2. 2. 2 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Meet Your Presenter Walter Capitani Director, Product Management Klocwork
  3. 3. 3 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork 1 2 3 What Medical Device Developers Try to Achieve Why Continuous Compliance Is Important How Static Analysis Can Help Here’s What We’ll Cover Today
  4. 4. What Medical Device Developers Try to Achieve
  5. 5. 5 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Compliance Goals Fulfill regulatory requirements. Certify your software to industry standards — such as IEC 62304. Get re-certified with each update. 1 2 3
  6. 6. 6 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Quality Goals Eliminate malfunctions. Reduce code rework. Deliver updates. 1 2 3
  7. 7. 7 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Security Goals Reduce security defects. 1 Connect your device securely. 2 Eliminate potential entry (hacking) points. 3 Protect patient privacy. 4
  8. 8. 8 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Coding Goals Enforce coding standards. Make code maintenance easier. Reduce the number of issues introduced when adding new features. 1 2 3
  9. 9. 9 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork How These Goals Are Met — Traditionally Compliance, quality, and security goals aren’t met until the end of development cycles. This leads to: More issues found at the end. Extra time to fix – and extra risk. Additional costs to fix these issues. 1 2 3
  10. 10. Why Continuous Compliance Is Important
  11. 11. 11 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork What Is Continuous Compliance? Continuously monitoring and maintaining compliance – with as much automation as possible.
  12. 12. 12 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Why Is Continuous Compliance Important? Continuous compliance reduces: Number of unknown issues. Risk — time-to-market, FDA compliance, security. Cost of rework. 1 2 3
  13. 13. How Static Analysis Can Help
  14. 14. 14 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Continuous Compliance Ensure continuous compliance with industry standards and regulatory requirements. Roll compliance into your process earlier. Get certified in compliance faster — and avoid delayed releases. Maintain compliance with each update.
  15. 15. 15 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Improve Security For Increasingly Connected Devices Identify potential security issues earlier. Prevent malicious attacks. Protect patient privacy. Comply with HIPAA.
  16. 16. 16 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork Enforce Corporate and Industry Coding Rules and Best Practices Improve the quality of your codebase. Deliver updates without issues. Reduce code rework. Decrease technical debt.
  17. 17. How can Klocwork help?
  18. 18. 18 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork About Klocwork • Delivers secure, reliable, and conformant code. • Finds bugs and security flaws earlier in development. • Prioritizes the most important issues. • Improves the quality and structure of your codebase. • Integrates with popular CI tools. • Accelerates time-to-market.
  19. 19. Questions?
  20. 20. Contact us to schedule a demo: info@roguewave.com
  21. 21. Follow us for news and insights! blog.klocwork.com

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