Regulatory software
Medical device regulatory software: what the category covers
Medical device regulatory software is a category of tools that help manufacturers plan, document and maintain the regulatory status of their devices. It overlaps with electronic quality management systems (eQMS), which focus on QMS processes and records, and with document management systems, which focus on versioning and approval. MDRpilot sits between them: it is product-centred like a regulatory tool, includes the QMS documents and records an ISO 13485 system needs, and adds AI-assisted drafting with controlled templates.
Who it is for
- Teams choosing their first regulatory tool
- Companies that outgrew spreadsheets but do not need a large enterprise eQMS
- Consultancies that need one workspace per client
Key capabilities
Product-centred
Every module reads from the same device record.
QMS included
Quality manual, procedures, document control and operational records alongside the technical file.
Roles
Owner, quality manager, regulatory affairs, consultant and viewer roles per company workspace.
Seven UI languages
English, Turkish, German, French, Spanish, Italian and Dutch, plus a document translator.
Types of tools you will meet
MDRpilot combines technical documentation, the QMS document set and quality records for EU MDR in one workspace. It is not a multi-market registration tracker and does not submit to authorities.
| Tool type | Typical focus |
|---|---|
| Document management system | Versioning, approval and distribution of controlled documents |
| eQMS | ISO 13485 processes: CAPA, complaints, audits, training, suppliers, change control |
| Regulatory information management | Registrations, submissions and certificates across markets |
| Technical documentation tools | Device files, GSPR, risk and clinical evaluation |
| General AI writing tools | Text generation without regulatory structure or traceability |
Questions that separate tools quickly
- Is the device description entered once and reused, or retyped in each document?
- Can a test report be linked to a GSPR row and a risk control, and is that link reviewed?
- Does a product change flag the documents that depend on it?
- Are AI drafts constrained by templates and confirmed facts, or free text?
- Can you export everything in formats your notified body accepts?
How the workflow runs
- 1
Define the product
Device description and classification.
- 2
Document
Technical file, risk, clinical and PMS.
- 3
Operate the QMS
Procedures, records and approvals.
- 4
Prepare for audit
Readiness view and simulator.
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 focuses on EU MDR. It does not manage registrations in other markets.
- It is a web application; there is no on-premise installation.
- It does not offer a validated computer system package; if you need computer software assurance documentation, plan that separately.
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 medical device regulatory software?
Software that helps manufacturers plan, document and maintain the regulatory compliance of their devices, such as technical documentation, risk management, clinical evaluation, post-market surveillance and QMS records.
Is MDRpilot an eQMS?
It includes eQMS functions such as document control, CAPA, complaints, internal audits, training and supplier evaluation, and combines them with MDR technical documentation.
Is MDRpilot itself a medical device?
No. MDRpilot is documentation and workflow software for manufacturers. It is not intended for diagnosis or treatment of patients.
Does MDRpilot support markets outside the EU?
Target markets can be recorded on the product, and ISO 13485 and ISO 14971 work applies widely. The regulatory content is built for EU MDR.
Can consultants use MDRpilot for clients?
Yes. Each client is a separate company workspace, and consultants can be invited with a consultant role.
Related workflows
- MDR software that keeps your technical file, evidence and quality records connectedWhat MDR software does, who needs it and how MDRpilot connects technical documentation, GSPR, risk, clinical, PMS and QMS work in one regulatory workspace.Read more
- Regulatory affairs software for medical device teamsTools for medical device regulatory affairs teams: classification rationale, technical file ownership, UDI data, translations and notified body readiness.Read more
- Medical device compliance software for the whole device lifecycleWhat compliance means for medical device manufacturers across the lifecycle, what software can and cannot do, and how MDRpilot keeps documentation and records consistent.Read more
- ISO 13485 software for quality manuals, procedures and controlled recordsBuild and run ISO 13485:2016 documentation: quality manual wizard, SOPs, forms, document control with review and approval, and a controlled document register.Read more
- MDR software: what to look for in 2026Objective criteria for choosing MDR software and how MDRpilot fits them.Read more
Guides and resources
- 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
- MDR Software for Small and Medium-Sized Medical Device ManufacturersWhat SMEs need from MDR software: small teams covering many roles, PRRC at disposal, limited budgets, consultant collaboration and a fast path from legacy files to MDR.Read more
- AI in Medical Device Regulatory AffairsWhere AI genuinely helps regulatory affairs teams, where it creates risk, how to control AI-generated content in a QMS and what the EU AI Act does and does not cover.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes — International Organization for Standardization.
- Medical devices sector — European Commission, Directorate-General for Health and Food Safety.
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.