The AI Analysis Engine component within PCR.AI is CE-IVDR & MHRA registered as a Class A medical device software. This component provides the automated interpretation of PCR results. The user interface and visualization components are non-medical device workflow components. This split architecture gives laboratories flexibility in how they implement PCR.AI within their quality systems.

PCR.AI supports laboratory accreditation by providing comprehensive documentation of analysis methods, automated quality controls, complete audit trails, and standardized reporting. The system reduces subjective interpretation, ensures consistent application of acceptance criteria, and provides evidence of compliance with defined procedures—all key factors in meeting ISO 15189, CAP, and CLIA requirements.

PCR.AI provides validation support appropriate to each tier. All customers receive access to our Validation Guide and standard IQ/OQ/PQ protocols. Enterprise customers receive additional validation assistance including custom protocol development and on-site validation support. OEM Partners receive comprehensive regulatory documentation designed to support manufacturer validation activities.

For Device Manager, updates are applied automatically during scheduled maintenance windows with advance notification to users. Enterprise Edition allows greater control over the update process, with test environments for validation before production deployment. Updates that affect the CE-IVDR & MHRA registered components follow our documented change control process with appropriate regulatory notifications.

Yes, PCR.AI is designed to be included within a laboratory's accreditation scope. We provide the necessary documentation to support method validation, including technical specifications, performance characteristics, and quality control procedures. Many accredited laboratories have successfully included PCR.AI in their ISO 15189, CAP, and CLIA accreditations.

Our regulatory team continuously monitors changes to relevant regulations including CE-IVDR, MHRA requirements, FDA guidance, HIPAA/GDPR, and laboratory accreditation standards. Updates to maintain compliance are prioritized in our development roadmap, and we provide advance notice of any changes that may impact customers' regulatory posture.