software
development
sometimes the smallest problems need the greatest focus
Our consultants have designed solutions for some of the most exacting software problems
in modern healthcare, including:
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instrument integration
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distributed messaging and communications
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advanced imaging
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computer assisted diagnosis
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management information tools
Our iterative, incremental design and development methodology is proven to deliver
results of a very high standard that meet agreed time and technology milestones.
systems
architecture
software and infrastructure in harmony
Although the software is a critical component of a successful solution, the infrastructure
and environment in which it executes is just as important.
Good solutions architecture is a balance of evolution and revolution - designing
systems that get the best out of your existing investment, and enhancing them where
necessary to take advantage of new concepts and technologies.
Our consultants are experienced in the design of complex network and data management
systems that can meet the demands of modern health information systems. Conversely,
we can identify bottlenecks in your software architecture that will prevent it from
running successfully in your existing environment.
We offer services that include
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systems audit
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systems design
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performance analysis
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security analysis
instrument
design and engineering
innovation is critical - pragmatism is mission critical
Ythos instrument design and engineering services address specific applications in
the healthcare and life science technology arena.
Ythos consultants are drawn from both academic and industrial backgrounds, providing
you with a powerful combination of theoretical and practical skills.
Whether the challenges you face relate to whole systems or components, Ythos provides
in-depth technology consulting services that help you to arrive at the project end
point quickly, efficiently, and within budget.
regulatory
affairs
getting it right is more than just a matter of accuracy
Ythos provides consulting services and resources to support regulatory submissions
including the FDA , European, and Asia Pacific regulation organizations with specific
emphasis on medical devices and software.
Submitting successful regulatory documents is not just about getting the detail
right: you have to explain to non-specialists how complex technology and methods
work. Clear, concise, and accurate communications are critically important in submissions.
20 steps to a successful submission - US FDA CDRF 510(K) example
- 1. Medical Device User Fee (FDA 3601)
- 2. CDRH Premarket Review Submission Cover Sheet
- 3. 510 (k) Cover Letter
- 4. Indications for Use Statement
- 5. 510 (k) Summary / 510 (k) Statement
- 6. Truthful and Accuracy Statement
- 7. Class classification Summary & Certification
- 8. Financial Certification / Disclosure Statement
- 9. Declarations of Conformity & Summary Reports
- 10. Executive Summary
- 11. Device Description
- 12. Substantial Equivalence Discussion & Data
- 13. Proposed Labelling
- 14. Sterilization & Shelf Life
- 15. Biocompatibility
- 16. Software
- 17. Electromagnetic Compatibility
- 18. Performance testing (Bench)
- 19. Performance testing (Animal)
- 20. Performance testing (Clinical)