Bring your MDR technical file to audit-ready — with traceability built in.
Structure Annex II/III dossiers, map GSPR evidence, draft ISO documents and measure audit readiness — before your notified body review.
Drafting & gap analysis only — not a substitute for Notified Body assessment.
Documentation debt slows market access
Technical files live in scattered folders and spreadsheets. GSPR evidence, risk files and IFUs are reconciled manually — and critical gaps surface only when the auditor asks.
One controlled dossier, end to end
MDRpilot unifies your MDR technical file, quality system and evidence links in a single workspace — with version history, gap analysis and a live readiness score.
Built for regulated medical device teams
Structured MDR technical files, ISO 13485 quality systems and audit preparation — with traceable evidence, a seven-language UI, AI document translation, and live quality operations (internal audit, calibration, CAPA and traceability).
MDR Technical File Builder
Generate an Annex II & III dossier structure tailored to your device class, with live completeness tracking across every section.
- Annex II/III structure per device profile
- Section status & missing-item alerts
- Export-ready DOCX, PDF & ZIP packages
GSPR Evidence Control
Map General Safety and Performance Requirements to linked evidence — and surface gaps before your notified body review.
- Clause-level requirement mapping
- Evidence linked to technical file sections
- Missing proof flagged with priority
Audit Readiness & Simulation
A live readiness score per product dossier, prioritized actions and an internal audit simulator — so nothing surprises you on audit day.
- 0–100 readiness index per product
- Prioritized gap closure actions
- Notified-body-style Q&A simulation
Internal Audit Cycles
Annual internal audit plan, checklist and report per year — with major/minor findings linked straight to CAPA.
- PLAN-IA / FORM-IA / REC-IA per audit year
- Clause checklist with OK, minor and major NC
- One-click CAPA from audit findings
Calibration & Measuring Equipment
Track measuring devices, calibration due dates and equipment records — aligned with SOP-ME and FORM-ME-01.
- Equipment register with next calibration date
- Overdue and open status alerts
- Export-ready calibration records
CAPA, Complaints & Post-Market
Live operational registers for CAPA, complaints, vigilance, traceability and training competency — closure loops built in.
- Complaint → CAPA and vigilance linkage
- Lot/serial traceability (ISO 7.5.9)
- Training competency matrix per SOP revision
Regulation-Aware Document Composer
Draft IFU, clinical evaluation, PMS/PMCF and QMS procedures with prompts grounded in MDR and ISO 13485 — not generic boilerplate.
- IFU, CER, PMS/PMCF & procedure drafts
- Human review & version history
- Metered tokens with plan quotas
Regulatory Document Translator
Upload Word, Excel or PDF regulatory documents and translate with AI while preserving structure — IFUs, procedures and technical annexes for multi-market dossiers.
- TR, EN, DE, FR, ES, IT and NL supported
- DOCX, XLSX and PDF in → structured export out
- Automatic source-language detection
Platform & Output Language Support
Work in Turkish, English, German, French, Spanish, Italian or Dutch across the UI; AI-generated drafts follow your language while MDR, ISO and annex references stay in standard form.
- Seven-language workspace with one click
- AI outputs aligned with UI language
- Regulatory identifiers never mistranslated
Risk Management File
Maintain a structured ISO 14971 workflow from hazard identification through residual risk — aligned with your design and clinical data.
- AI-assisted hazard suggestions
- 5×5 matrix & residual risk log
- Traceability to design controls
ISO 13485 Quality System
A controlled document center for mandatory QMS procedures, approvals and your quality manual — audit-ready from day one.
- 18 mandatory procedures, versioned
- Document control & approval flow
- Quality manual wizard included
One suite for the full regulatory dossier
Every module shares the same product context, evidence links and audit trail — no duplicate data entry.
Technical File
Annex II & III structure with section-level status tracking
GSPR Checklist
Clause mapping, evidence links and missing-proof alerts
Risk Management
Hazard log, 5×5 matrix and residual risk traceability
Clinical Evaluation
CER structure, literature review and equivalence tracking
PMS / PMCF / PSUR
Post-market plans, vigilance hooks and PMCF alignment
IFU & Labeling
Instructions for use drafts and label compliance checks
QMS Documents
18 mandatory procedures with document control workflow
Document Translator
AI translation for DOCX, XLSX and PDF with layout-aware export
Multilingual Workspace
Switch UI across TR, EN, DE, FR, ES, IT and NL; aligned export labels
Export Center
Technical file ZIP, checklists, risk files and audit packs
Before vs. after MDRpilot
Before
- Technical files scattered across folders
- GSPR evidence unclear
- Audit preparation is manual
- Consultants are expensive
- MDR gaps found late
After
- AI-generated documents
- Clause-based gap analysis
- Evidence-linked GSPR
- Built-in audit simulator
- Export-ready technical file
Built for medical device teams
However you bring devices to market.
Manufacturers
Prepare MDR technical files and ISO 13485 QMS in-house.
Regulatory consultants
Scale clients with clause-level gap analysis and reports.
Startups
Stand up an audit-ready dossier without a large team.
Simple, transparent pricing
Start free, upgrade when you scale.
Basic
- 1 product
- 1 seat
- Live AI drafting
- Export center
- ~500k AI tokens / mo (1 full dossier)
Plus
- 3 products
- 3 seats
- Live AI drafting
- Export center
- ~1.5M AI tokens / mo (3 full dossiers)
Pro
- 5 products
- 5 seats
- Live AI drafting
- Export center
- ~2.5M AI tokens / mo (5 full dossiers)
Enterprise
- Unlimited products
- SSO & roles
- Private AI / RAG
Need help? Talk to our team
Technical questions, billing, onboarding or regulatory workflow — send us a message and attach screenshots if helpful. We will help you move forward quickly.
- Direct line to the MDRpilot team — no ticket maze.
- Typical reply within one business day.
- Logged-in users also reach support from Help in the app sidebar.
support@mdrpilot.com
Contact support
We typically reply within one business day.
Frequently asked questions
Does MDRpilot give regulatory approval?
No. MDRpilot produces drafts, gap analyses and checklists. Final regulatory decisions remain with your qualified person and Notified Body.
Which standards are covered?
MDR 2017/745, ISO 13485, ISO 14971, plus referenced standards like ISO 10993, ISO 11607 and IEC 62304.
Is my data isolated?
Yes. Every company is fully isolated; no company can access another's files or documents. AI keys never reach the browser.
Can I run it without an AI key?
Yes. A deterministic mock engine runs the entire platform offline, with a graceful fallback if a live provider fails.