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.Get in touch →
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.Get in touch →
Just have a few pressing questions? Need an architecture review or a quick troubleshooting session? Get advice on risk analysis, architecture, testing, or anything else software-related.
As much or as little as you need.Get in touch →
"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