We can help your team meet aggressive development time-lines. Our engineers are familiar with medical device development, the relevant FDA guidance, and IEC 62304. We can work within your QMS or within our QMS.
We’re able to add and remove resources to your team as needed for smaller projects.
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.
We also help companies write DICOM conformance statements.