ISO 13485 · QMS
ISO 13485 software for quality manuals, procedures and controlled records
ISO 13485 software helps a medical device manufacturer create, control and use the documentation required by ISO 13485:2016, the quality management system standard for medical devices. That includes the quality manual, documented procedures, forms, records and the medical device file (clause 4.2.3). MDRpilot provides a quality manual wizard, procedure drafting in controlled templates that build on each other, document control with reviewer, approver and release steps, and a document register, together with the operational records the procedures call for.
Who it is for
- Companies building an ISO 13485 QMS from scratch
- Quality managers replacing paper or shared-drive document control
- Manufacturers aligning an existing QMS with MDR Article 10(9)
Key capabilities
Quality manual wizard
Company profile, scope and exclusions lead to a quality manual draft for ISO 13485, ISO 9001 or both.
Procedure set
Procedures, forms, instructions, plans and lists in a layered folder structure.
Document control
Revision, reviewer, approver and release steps; approved documents stay effective until a new revision is released.
Document register
Controlled document list with status, exportable as XLSX.
Operational records
CAPA, complaints, internal audit, nonconforming product, change control, management review, training, suppliers and calibration.
Reminders
Email reminders for periodic reviews and due actions.
What ISO 13485 asks you to document
| Clause | Typical documents and records |
|---|---|
| 4 Quality management system | Quality manual, control of documents and records, medical device file |
| 5 Management responsibility | Quality policy, objectives, management review |
| 6 Resource management | Competence and training records, infrastructure, work environment |
| 7 Product realisation | Planning, design and development, purchasing, production, traceability, monitoring equipment |
| 8 Measurement, analysis and improvement | Feedback, complaints, regulatory reporting, internal audit, nonconforming product, CAPA |
How procedures are drafted without inventing facts
General company facts such as legal name, address, sites, markets, responsible roles and record retention periods live in the company profile and are reused in every document. Before a procedure such as CAPA is generated, MDRpilot asks only the questions specific to that procedure, for example the root-cause method or the closure approver. Anything not yet decided appears as [TO BE CONFIRMED] in the draft instead of a guessed value.
The first procedures build on each other in a fixed order: document control, record control, organisation, risk management and CAPA, so later procedures reference the earlier ones consistently.
How the workflow runs
- 1
Profile
Enter company facts once in the profile.
- 2
Manual
Generate and approve the quality manual.
- 3
Procedures
Answer procedure-specific questions and draft each SOP.
- 4
Control
Review, approve and release documents.
- 5
Operate
Use the records the procedures define.
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 certify your QMS. Certification is done by an accredited certification body or, for MDR, assessed by your notified body.
- Procedures must reflect how your company actually works; drafts need to be adapted and approved.
- ISO 13485 text is copyrighted; MDRpilot refers to clause structure without reproducing the standard.
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 support ISO 13485?
Yes. It covers the quality manual, procedures, forms, document control, a document register and the quality records ISO 13485:2016 requires.
Will using MDRpilot make us ISO 13485 certified?
No. Certification requires an audit by a certification body. MDRpilot helps you build and run the documented system that is audited.
Can we import our existing procedures?
You can upload existing documents as files and keep working in MDRpilot's document control for new revisions.
Does it cover ISO 9001 as well?
The quality manual wizard can produce a manual for ISO 13485, ISO 9001 or both. The rest of the content is built for medical devices.
How does MDRpilot avoid inconsistent company data across SOPs?
General facts come from the company profile and are reused in every document; only procedure-specific decisions are asked before each procedure is drafted.
Related workflows
- 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
- CAPA software that closes the loop with complaints, audits and riskRun corrective and preventive actions under ISO 13485 clause 8.5: sources, root cause, actions, effectiveness checks and links to complaints, audits 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
- 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
- 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
Guides and resources
- ISO 13485 for Medical Device ManufacturersWhat ISO 13485:2016 requires, how it differs from ISO 9001, how it relates to MDR Article 10(9), which documents you need and how certification works.Read more
- Medical Device CAPA GuideHow to run CAPA under ISO 13485 clause 8.5 and MDR: when to open a CAPA, root cause analysis, actions, verification, effectiveness checks and links to risk and PMS.Read more
- MDR Audit Preparation ChecklistA practical checklist for notified body QMS audits and technical documentation reviews under the EU MDR, including unannounced audits, records to have ready and how to rehearse.Read more
References
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes — International Organization for Standardization.
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
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.