MDRpilot at a glance

• Medical device manufacturers preparing or maintaining EU MDR technical documentation
• Regulatory affairs and quality assurance teams
• Small and medium-sized manufacturers without a large in-house regulatory department
• Regulatory consultants who manage several client files
• Persons responsible for regulatory compliance (PRRC) who need an overview of open gaps

• MDR technical documentation

  Product-level technical file structured along MDR Annex II and Annex III, with section status (missing, draft, approved), AI-assisted drafts, manual editing and evidence attachments.

• Annex VIII classification assistant

  Question-based helper that suggests a device class and the applicable Annex VIII rule with a written rationale. The manufacturer confirms the class.

• GSPR checklist and evidence matrix

  Annex I General Safety and Performance Requirements with applicability, justification for non-applicable items, linked standards and linked evidence files.

• ISO 14971 risk management file

  Risk management plan, hazard analysis and FMEA-style risk items with risk controls and verification of control effectiveness.

• Clinical evaluation

  Clinical evaluation plan and report structure, literature search in PubMed and Europe PMC with PRISMA-style screening counts, equivalence data, a clinical gap matrix and a review and approval step.

• Post-market surveillance

  PMS plan, PMCF plan and survey, and PSUR or PMS report outlines based on device class, connected to complaints and CAPA records.

• Design control traceability

  Design input, output, review, verification, validation and transfer records with a traceability matrix (ISO 13485 clause 7.3) that can reference risk and clinical items.

• Instructions for use

  IFU drafting from product data, structured around the information supplied with the device (MDR Annex I, Section 23).

• ISO 13485 QMS documentation

  Quality manual wizard, procedures (SOPs), forms and instructions with document control, revision and approval workflow and a controlled document register.

• Quality records

  CAPA, complaints, internal audit, FSCA, vigilance, change control, management review, supplier evaluation, traceability, calibration and training matrix records.

• Evidence files

  Upload of test reports and other evidence; automated analysis suggests links to GSPR rows, risk controls and clinical evidence, which a user confirms before they are applied.

• Change impact flags

  When product data such as class, sterilisation or intended purpose changes, documents that depend on it are flagged for review.

• Audit readiness and audit simulator

  Readiness score with a list of missing actions across technical file, QMS and CAPA, plus an audit simulator (MDR, ISO 13485, ISO 14971 or combined scope) that records findings as major, minor, observation or positive.

• Exports

  Technical file DOCX and full ZIP, GSPR and risk XLSX, IFU DOCX, label PDF, PMS/PMCF DOCX, QMS package ZIP and document register XLSX, plus UDI device data XML for manual EUDAMED preparation.

• Document translator

  Translation of regulatory documents between the supported languages with medical terminology handling.

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• GSPR compliance
• ISO 14971 risk management
• Clinical evaluation software
• PMS and PMCF software
• ISO 13485 software
• Audit readiness
• Security
• Resources
• Glossary
• Case studies (illustrative)
• How to evaluate MDR software
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• Distance sales agreement

Machine-readable summaries: llms.txt, llms-full.txt and product-info.json.