We can help your team meet aggressive development timelines. Our engineers are familiar with the medical device development process and can integrate seamlessly with your existing processes.
We have expertise with these technologies:
We also have worked with the following, although less often:
Many medical device startups wisely keep their functionality to a minimum for their first premarket submission. Once you’re on the market, customers often ask you to integrate with EMRs and PACS. We know HL7 and DICOM. Over 10,000 engineers and radiologists visit our DICOM Standard Browser each month, and it is often the top result in DICOM-related Google searches.
Do your developers complain that regulatory documentation is a waste of their time? Is documentation mostly written after development is complete? Are there many manual steps involved?
Some manual processes that may be manageable for small projects quickly become unscalable.
We’ve helped several companies improve their software documentation processes using our open-source regulatory documentation manager (RDM) platform. Not only does this save time, but it also helps with morale; engineers hate feeling like their wasting time. When done during the appropriate stage of the development lifecycle, we believe most regulatory documentation is worthwhile.