Services
Embedded Software Development
Everything you need for the software portion of your FDA submission
Surgical tools, patient monitors, POC diagnostic and treatment devices...
I can deliver a complete, fully-verified, embedded software and documentation package. I collaborate closely with you and your team to define requirements, and handle all software design inputs. I can work with your QA team to perform software and system V&V, or work with outside partners to handle V&V for you.
Ready to be included in your Design History File and regulatory submission.
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Complete firmware development through 510(k)
for Centricity Vision's ZEPTO console.
IEC 62304 Compliance
Quality without the Overhead
Do you have a software team, but aren't confident that your process or documentation will pass muster with the FDA?
Do you have procedures written that don't make sense and that your software team never looks at?
I can help you understand what you need to do, how your documentation should be written, and everything you have to know for a successful regulatory submission.
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"We had a control software issue that had plagued us for a long time. Jeff diagnosed and confirmed the root cause, permanently solved the problem, and made the device work well in one day. He then delivered a great learning session for the engineering team so they were empowered to fix this kind of issue themselves in the future."
— Mike White, VP of Product Development at Veranex
