Medical device QMS
A medical device QMS that is connected to your devices
A medical device quality management system (QMS) is the set of processes, responsibilities and records a manufacturer uses to design, produce and monitor devices consistently and in line with regulation. MDR Article 10(9) lists the aspects the QMS must address, from the regulatory compliance strategy and GSPR identification to risk management, clinical evaluation, PMS, vigilance and CAPA. ISO 13485:2016 is the standard most manufacturers use to meet these requirements. The QMS is not a separate binder: its outputs feed the technical documentation of every device.
Who it is for
- Founders and quality leads setting up a medical device company
- Manufacturers whose QMS was built for ISO 13485 but not for MDR
- Teams preparing for a QMS audit under Annex IX
Key capabilities
Design control traceability
Design input, output, review, verification, validation and transfer with a traceability matrix (ISO 13485 clause 7.3).
Procedure chain
Core procedures drafted in order so they reference each other consistently.
Quality records
CAPA, complaints, FSCA, vigilance, change control, management review, suppliers, calibration, training.
Company profile as source
Roles, sites, markets and retention periods entered once and used in every document.
What MDR Article 10(9) expects from the QMS
- A strategy for regulatory compliance, including conformity assessment and management of modifications
- Identification of applicable GSPRs and options to address them
- Responsibility of management and resource management, including suppliers
- Risk management and clinical evaluation, including PMCF
- Product realisation, including planning, design, development, production and service
- UDI assignment and verification
- Post-market surveillance, communication with authorities and notified bodies, and vigilance reporting
- Corrective and preventive actions and verification of their effectiveness
- Monitoring, measurement and analysis of output, data analysis and product improvement
Why the QMS and technical file must be linked
Design control records support Annex II Section 3. Supplier controls support the manufacturing information. CAPA and complaint records support PMS and the risk file. When the QMS and device documentation sit in different tools, these links become manual cross-references that drift. In MDRpilot they share one workspace: design control records can reference risk and clinical items, CAPA can be tied to a product, and the readiness view counts QMS and product gaps together.
How the workflow runs
- 1
Scope
Define products, sites and processes in scope.
- 2
Document
Manual and procedures with document control.
- 3
Operate
Records for design, suppliers, production and feedback.
- 4
Improve
Internal audit, management review and CAPA.
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
- The QMS is defined by how your company works; MDRpilot provides structure and drafts, not a ready-made system.
- MDRpilot does not run production systems such as ERP or MES.
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
Is ISO 13485 certification required under MDR?
MDR requires a QMS that covers Article 10(9). ISO 13485 certification is not legally required, but EN ISO 13485 is the harmonised standard most manufacturers use, and the notified body assesses the QMS as part of conformity assessment.
What is the medical device file?
ISO 13485 clause 4.2.3 requires a file for each device type or family with its description, specifications, procedures and records. Under MDR it overlaps with the technical documentation.
Can MDRpilot manage design control?
Yes. Design control records from input to transfer are kept per product with a traceability matrix.
Does MDRpilot cover supplier management?
Supplier evaluation and an approved supplier list are part of the operational records.
Who can approve documents?
Approval steps are assigned to users with the appropriate role in your company workspace.
Related workflows
- 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
- 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
- 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
- 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
- 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
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
- 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
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.
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.