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We employ a well defined business process refined from years of validated
development efforts in clinical diagnostics and consumer health care,
creating products requiring FDA 510-K submissions. We
apply this expertise to advantage on all projects, regardless of
the industry or application. The result is a more predictable and reliable
outcome that can be measured and continuously improved.
The Orion Process is both agile and validated, allowing work
to proceed un-encumbered, while still maintaining a
well defined and traceable effort. We also offer a web-accessible
quality management tracking system to keep clients appraised of open issues for
advanced development projects.
To the benefit of our clients in the healthcare industry, our experience
allows us to employ methodologies that are sensitive to HIPAA and FDA
requirements. Our technical team is trained in the regulatory issues
surrounding IT development and documentation, and we maintain thorough
Standard Operating Procedures (SOP) for software development. In addition
to improving quality and efficiency, our SOPs are structured to support FDA
regulatory guidelines, including full traceability.
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