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.

1. The Key to Continuous Compliance for
Medical Device Software Developers
WALTER CAPITANI, DIRECTOR, PRODUCT MANAGEMENT, KLOCWORK | APRIL 4, 2019

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 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork
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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. What Medical Device Developers Try to Achieve

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.
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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.
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7. 7 | The Key to Continuous Compliance For Medical Device Software Developers roguewave.com/products-services/klocwork
Security Goals
Reduce security
defects.
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Connect your
device securely.
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Eliminate
potential entry
(hacking) points.
3
Protect patient
privacy.
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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.
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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.
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10. Why Continuous Compliance Is Important

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 | 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.
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13. How Static Analysis Can Help

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 | 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 | 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. How can Klocwork help?

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. Questions?

20. Contact us to schedule a demo:
info@roguewave.com

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