RAccelerator turns regulatory requirements into device-specific workflows and remediation plans, accelerating compliance, creating traceable and reproducible technical documentation without sacrificing quality, control and auditability.
RAccelerator will evaluate your device documentation against applicable ISO standards and GSPR, and provide a detailed overview of gaps and potential remediation.
RAxy, the RAccelerator chatbot, walks you through the classification rules. It will provide the device classification with accuracy level and the classification determination report for your technical documentation.
When gaps are identified, RAccelerator will provide a remediation plan with estimated timelines and generic cost.
RAccelerator can read your PDFs, DOCX, and XLSX documents. It will organize them under the applicable GSPR.
RAccelerator will provide a status report with the level of detail required for the audience — whether it is an RA professional, R&D Engineer, or C-suite.
RAccelerator is 21 CFR Part 11 compliant and provides full traceability of data and evidence.
“RAccelerator cut our GSPR assessment time from 12 weeks to 3. The deterministic AI means we trust every output our NB sees.”
“Finally, a tool that understands MDR at the standard-clause level. The gap analysis saved us from two critical findings at our stage 2 audit.”
A Class IIb cardiac device manufacturer reduced their submission timeline from 9 months to under 4 using RAccelerator’s automated GSPR assessment and gap remediation workflow.