Detailed rules, fast updates
Hundreds of NMPA guidelines and regulatory documents are under continuous revision — tracking them by hand makes key changes easy to miss.
MedBuddy · AI for medical device registration documents
An AI assistant that understands both NMPA regulations and your company's own rules. Regulation templates drive generation, a rules engine drives validation, and your internal conventions are built into the wording — so every document is built on a compliant skeleton, freeing the registration team from repetitive drafting.
30+Registration document types
500+Regulatory knowledge entries
60%Faster authoring
92%QC coverage
Three pressures behind every registration document
Heavy internal rules, repetitive work
Most authoring time goes on formatting and cross-checking entries; less than 40% is spent on the professional content itself.
Manual QC, late detection
A single document goes through three or more rounds of internal rework, and consistency or compliance issues often surface only at the review stage.
Three core capabilities
Intelligent authoring
Using the regulation template library and your product materials, it produces structurally complete drafts with all required elements; wording and format follow your internal rules, reaching over 80% completeness before human review.
Compliance QC
A built-in rules library checks completeness, accuracy and cross-document consistency item by item; risks are flagged as high, medium or low, with one-click jumps to the source paragraph.
Regulation & SOP management
NMPA regulations, guidelines and industry standards are synced automatically; your SOPs and historical submissions are structured and embedded; every generation, edit and approval is logged.
Product capabilities
Intelligent document generation
Driven by the regulation template library — a structurally complete, element-complete compliant draft in one step.
- Template-driven: structure, sections and submission elements pre-built to NMPA requirements, preventing omissions at source
- Automatic company data: enter the product name, model and company details once and reuse them across every linked document
- Linked multi-document updates: when product information changes, affected documents are identified and flagged for revision
Compliance QC engine
QC moves into the authoring process, turning experience-based manual checking into an executable checklist.
- Regulatory clause completeness
- Cross-document consistency
- Values, units and format accuracy
- Citation and version validity
- Risk grading and one-click location
Regulation & SOP management
External regulations and internal SOPs aligned on two tracks, making compliance the default property of every document.
- Automatic regulation sync: updated regulations, guidelines and standards are ingested, and affected documents are flagged for revision
- Internal rules embedded: SOPs, document templates and historical submissions are structured, so the right company process and wording are matched automatically
- Fully traceable: generation, edits and approvals all logged, any version comparable in one click — the record is the evidence chain for audits
Four-step generation flow
From blank page to compliant draft, the registration team focuses only on professional judgement and revision.
- 1 Select document type — choose from 30+ templates
- 2 Match the regulatory template — structure and submission elements applied automatically
- 3 AI generates the draft — product materials combined into an element-complete draft
- 4 Human confirmation — review and finalise in one step
Coverage
Document types covered
- Product technical requirements
- Clinical evaluation materials
- Instructions for use and labelling
- Risk management reports
- Software and cybersecurity descriptions
- Quality system documents
Regulatory frameworks covered
- NMPA regulations
- Departmental rules
- Guidelines
- Industry standards
Extendable to FDA, MDR and other multi-market frameworks to match your export needs.
Value delivered
60%Shorter authoring cycle
3xQC efficiency
92%Issues found before submission
45%Less rework
With vs without: the same registration project
Authoring cycle per document20 working days → 8 working days
Share of time on manual checking100% → 45%
When compliance issues surfaceReview stage → before submission
The efficiency and QC figures above are indicative; before a formal engagement they can be replaced with measured data from a pilot project.
Delivery and pricing
Delivery
Software platform deployment plus large-model integration, available on-premise or in the public cloud, so company documents never leave your domain.
Deployment and support
GPU hardware for on-premise deployment is borne by the client, sized to team and workload; ongoing support after go-live covers knowledge base and model upgrades.
Pricing
Priced on request, based on team size, deployment model and functional scope.
Pricing excludes hardware and public-cloud token costs.
Frequently asked questions
The questions our clients ask most. You can also ask the AI assistant in the bottom-right corner.
Which documents can MedBuddy generate?
30+ document types including technical requirements, clinical evaluation materials, instructions for use and labelling, risk management reports, software and cybersecurity descriptions, and quality system documents.
What is the quality of the output?
A regulation template library drives generation: structure and submission elements are pre-built to NMPA requirements, company data is filled automatically and linked documents update together, reaching over 80% draft completeness.
What exactly does the compliance QC check?
Five dimensions: clause completeness, cross-document consistency, values/units/format, citation and version validity, and risk grading with one-click location.
How is MedBuddy priced?
MedBuddy is quoted on request, depending on deployment model and document coverage. Email team@teamonsoft.com with your requirements.
Want to see how these products work?
Tell us your document types and team size, and we will arrange a focused demo and proposal.