MDR software
MDR software that keeps your technical file, evidence and quality records connected
MDR software is software that helps medical device manufacturers meet the documentation and process obligations of the EU Medical Device Regulation (EU) 2017/745. It typically covers the technical documentation in Annex II and III, the General Safety and Performance Requirements in Annex I, risk management, clinical evaluation, post-market surveillance and the quality management system. MDRpilot is an AI-assisted regulatory workspace that keeps these pieces in one product record, so a change in one place shows up wherever it matters and open gaps are visible before an audit.
Who it is for
- Manufacturers moving legacy MDD devices to MDR certificates
- Start-ups preparing a first MDR submission
- Quality and regulatory teams that maintain several device files
- Consultants who manage technical files for clients
Key capabilities
One product record
Device class, intended purpose, sterilisation, target markets and applied standards are entered once and reused by every module and document.
Evidence that links itself, with your confirmation
Uploaded test reports are analysed and matched to GSPR rows, risk controls and clinical evidence. Nothing is linked until a user confirms it, and failed tests raise a gap instead of a link.
Change impact flags
When you change the class, sterilisation method or intended purpose, the documents that depend on that field are flagged for review.
Controlled AI drafting
AI drafts section bodies inside locked templates. Facts that are not confirmed in your company profile are marked [TO BE CONFIRMED] rather than invented.
Audit readiness
A readiness score and a list of missing actions across the technical file, QMS and CAPA, plus an audit simulator for rehearsal.
Why spreadsheets and folders stop working under MDR
MDR requires the technical documentation to be kept up to date over the device lifecycle (Article 10). In practice that means the GSPR checklist, the risk management file, the clinical evaluation report and the post-market surveillance documents must stay consistent with each other and with the current device description. When those live in separate folders, a change to the intended purpose or sterilisation method rarely reaches every document that depends on it.
Notified body reviewers check exactly these cross-references: whether every applicable GSPR has evidence, whether risk controls are verified, whether clinical claims match the IFU, and whether PMS data feeds back into risk and clinical evaluation. MDR software earns its place when it makes those links explicit.
What MDRpilot covers
| Area | What you do in MDRpilot |
|---|---|
| Technical documentation | Annex II and III structure per product, section status, drafts, evidence attachments, DOCX/PDF/ZIP export |
| GSPR | Annex I checklist with applicability, justification, standards and linked evidence |
| Risk management | ISO 14971 plan, hazard analysis, risk controls and verification of control effectiveness |
| Clinical evaluation | CEP and CER structure, literature search, equivalence data, clinical gap matrix |
| Post-market | PMS plan, PMCF plan and survey, PSUR or PMS report outline by device class |
| Quality system | ISO 13485 manual, procedures, document control, CAPA, complaints, audits, training |
| Audit | Readiness score, missing actions, audit simulator |
How the workflow runs
- 1
Create the product
Enter the device description and use the Annex VIII assistant to document the classification rationale.
- 2
Work the requirements
Mark GSPR applicability, attach standards and upload evidence; confirm suggested links.
- 3
Build the documents
Draft technical file sections, risk file, CER and PMS documents from the same data.
- 4
Close gaps
Use the readiness view and CAPA records to close what is still open.
- 5
Export
Export the technical file and module documents as DOCX, PDF, XLSX or ZIP for your notified body.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- MDRpilot does not perform conformity assessment, issue certificates or replace a notified body.
- AI output is a draft. A qualified person in your organisation must review and approve it.
- Test reports, clinical data and design records come from you; MDRpilot organises and checks them but cannot create evidence.
- EUDAMED submission is not automated. MDRpilot can prepare UDI device data XML for manual use.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.
Frequently asked questions
What is MDR software?
Software that helps medical device manufacturers prepare and maintain the documentation and processes required by Regulation (EU) 2017/745, such as the technical file, GSPR checklist, risk file, clinical evaluation and PMS documents.
Does MDRpilot replace a notified body?
No. MDRpilot is documentation and workflow software. Conformity assessment, certificates and final decisions stay with your notified body and your own qualified people. MDRpilot helps you arrive with a complete, traceable file.
Can MDRpilot generate a technical file?
It can draft the sections of an Annex II and III technical file from your product data and evidence, and export them as DOCX, PDF or ZIP. The content still has to be reviewed, completed with your own evidence and approved by your team.
Does MDRpilot replace a regulatory consultant?
No. It reduces the manual work of structuring, cross-checking and drafting. Many teams use it together with a consultant, who can be invited into the workspace with a consultant role.
Which device classes are supported?
Class I (including Is, Im and Ir), IIa, IIb and III. Class-dependent outputs, such as PSUR frequency, follow the device class you set on the product.
Can I try it before buying?
Yes. You can request a 3-day demo of the Suite at sign-up, or create a free Starter account for Document Studio.
Related workflows
- Technical file software for MDR devicesBuild and maintain an MDR technical file per device: Annex II and III structure, section status, AI-assisted drafts, linked evidence and DOCX, PDF or ZIP export.Read more
- GSPR compliance with evidence you can traceMap every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.Read more
- ISO 14971 risk management software connected to your evidenceMaintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.Read more
- Clinical evaluation software for the CEP, literature and CERPlan and document MDR clinical evaluation: CEP, literature search in PubMed and Europe PMC, equivalence, clinical gap matrix and CER with review and approval.Read more
- PMS and PMCF software that feeds back into risk and clinical evaluationPost-market surveillance under MDR Articles 83–86: PMS plan, PMCF plan and survey, PSUR or PMS report by device class, linked to complaints, CAPA and risk.Read more
- Audit readiness for MDR and ISO 13485 auditsPrepare for notified body and internal audits with a readiness score, a list of missing actions across technical file, QMS and CAPA, and an audit simulator.Read more
Guides and resources
- What Is EU MDR 2017/745?A plain explanation of the EU Medical Device Regulation 2017/745: scope, key dates, classification, conformity assessment, economic operators and what changed from the MDD.Read more
- EU MDR Technical Documentation: Complete GuideWhat EU MDR technical documentation is, who reviews it, how long to keep it, how it connects to the QMS and how to keep it current over the device lifecycle.Read more
- MDR Technical Documentation Software ComparisonA neutral framework for comparing MDR technical documentation software: criteria, questions to ask vendors, a scoring template and what MDRpilot does and does not offer.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Medical devices: new regulations — European Commission, Directorate-General for Health and Food Safety.
- Guidance: MDCG endorsed documents and other guidance — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.