Compliance
Medical device compliance software for the whole device lifecycle
Medical device compliance software helps manufacturers keep their devices, documentation and quality processes in line with the regulations that apply to them throughout the lifecycle: design, conformity assessment, placing on the market, post-market surveillance and change. For the EU that means Regulation (EU) 2017/745 and the standards used to demonstrate conformity, such as ISO 13485 and ISO 14971. Compliance is demonstrated by evidence and assessed by notified bodies and authorities; software can make that evidence complete, consistent and easy to find.
Who it is for
- Management teams that need a clear view of compliance status
- Small manufacturers with one person covering quality and regulatory
- Investors and acquirers performing regulatory due diligence with the manufacturer
Key capabilities
Status at a glance
Section status, GSPR evidence coverage, CAPA status and readiness score.
Change impact
Product changes flag dependent documents for review.
Activity log
Changes, approvals and AI generations are recorded with user and time.
Executive summary
A management view of open items across products.
Compliance across the lifecycle
| Lifecycle stage | Typical compliance work |
|---|---|
| Design | Design controls, risk management, GSPR identification, usability and software lifecycle where relevant |
| Conformity assessment | Technical documentation, clinical evaluation, QMS audit, certificates |
| Placing on the market | UDI, labelling and IFU, EUDAMED registration, PRRC |
| Post-market | PMS, PMCF, PSUR, complaints, vigilance, trend reporting |
| Change | Change control, impact assessment, notified body notification of significant changes |
What software can and cannot do
- Can: keep requirements, evidence and documents linked and current
- Can: show which items are missing, overdue or unapproved
- Can: draft documents from confirmed facts for review
- Cannot: decide whether evidence is sufficient
- Cannot: certify a device or guarantee compliance
- Cannot: replace qualified people required by the regulation, such as the PRRC
How the workflow runs
- 1
Inventory
Add products and record their status.
- 2
Fill gaps
Work through missing sections and evidence.
- 3
Control change
Review flagged documents after each change.
- 4
Monitor
Track PMS, CAPA and readiness over time.
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
- Compliance obligations differ by device and market; MDRpilot focuses on EU MDR.
- Software cannot detect that a document is untrue; it relies on the evidence you provide.
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
Does MDRpilot guarantee compliance?
No. It organises your documentation and shows gaps. Compliance is demonstrated by your evidence and assessed by your notified body and the competent authorities.
Does MDRpilot ensure CE certification?
No. CE marking of devices that need a notified body follows a successful conformity assessment by that notified body. MDRpilot helps you prepare the documentation that is assessed.
Can management see compliance status?
Yes. The executive and audit readiness views summarise open items across products and the QMS.
What happens when a product changes?
Changes to fields such as class, sterilisation or intended purpose flag the documents that depend on them, so they can be reviewed and updated.
Is there an audit trail?
Yes. The activity log records changes, approvals and AI generations with user and timestamp.
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
- 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
- MDR gap analysis that turns findings into actionsFind what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.Read more
- A medical device QMS that is connected to your devicesWhat a medical device quality management system must cover under MDR Article 10(9) and ISO 13485, and how it connects to technical documentation and PMS.Read more
- Software for the obligations in Regulation (EU) 2017/745Software support for the obligations in Regulation (EU) 2017/745: Article 10 manufacturer duties, Annex I GSPR, Annex II/III documentation, clinical evaluation and PMS.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
- MDR Gap Analysis GuideHow to run an MDR gap analysis on a technical file and QMS: scope, inputs, a structured review by Annex, prioritisation of findings and turning gaps into a plan.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
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.
- NANDO: notified bodies database — 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.