Regulatory Qualification
Take every component of your deployment and qualify it against the regulations and interoperability standards that actually apply, not just the ones your team remembers.
Overview
A medical device deployment touches a dozen regulated standards. Most teams know two or three intimately and assume the rest will be fine. The rest turn into the surprise findings at the wrong moment.
We run the qualification systematically (every software component, every interface, every storage tier) against the applicable regulations, and produce a single map showing what is covered, what is borderline, and what is open exposure.
Our Process
-
1
Component inventory
Every software, firmware, hardware, and SaaS component in the deployment.
-
2
Regulation map
Applicable regulations per component: IEC 62304, ISO 14971, HL7, FHIR, DICOM, HIPAA, Part 11.
-
3
Gap assessment
Per component × regulation cell: covered, partial, or open.
-
4
Remediation plan
Open gaps prioritized by risk and effort.
-
5
Sign-off package
QA-ready package linking each component to its regulatory evidence.
Frequently Asked Questions
Do you handle EU MDR?
Yes, alongside FDA. Most products today are dual-market.
What about SOUP and third-party components?
Explicitly covered, IEC 62304 SOUP analysis with vendor evidence requests.
Can this support a 510(k) submission?
Yes, the qualification artifacts plug into your submission package.
Does this work for AI/ML components?
Yes, GMLP principles layered on top of the standard regulatory map.
Find the regulatory gaps before the auditor does.
Send us your deployment architecture. We will return a regulation map and gap report within six weeks.
Start a Conversation