Medical device QMS software for ISO 13485 and the QMSR
Keep document control, competence records, complaints, nonconformities, CAPAs and change control in one eQMS, ready for your notified body audit and for FDA inspections under the QMSR.
What your QMS must cover, and where it lives in QFacts
Each requirement links to the module that handles it. The references name the chapter or clause an inspector will check.
Document and record control
Review and approve procedures, work instructions and forms with version control and electronic signatures. Each approved revision gets an effective date, and superseded versions stay on record.
ISO 13485 4.2.4ISO 13485 4.2.5See how it worksCompetence and training records
Assign training by curriculum, test it with a quiz and keep a signed record of every attempt, so you can show who is competent for which procedure.
ISO 13485 6.2See how it worksComplaint handling
Record each complaint with its source, assess recurrence and impact, and close complaints without impact with a signed QA assessment. Complaints with impact move into an investigation.
ISO 13485 8.2.2See how it worksNonconformities and deviations
Log nonconforming product and process deviations with the impacted batches, then let QA decide whether to investigate or close.
ISO 13485 8.3See how it worksCorrective and preventive action
Link CAPAs to the investigation that found the root cause, assign owners and due dates, and verify effectiveness before closure.
ISO 13485 8.5.2ISO 13485 8.5.3See how it worksChange control
Document the current state, the proposed state and the justification, assess the impact and add board approval where needed. Every decision is signed.
ISO 13485 4.1.4ISO 13485 7.3.9See how it worksElectronic records and signatures
Unique user accounts, role-based access, electronic signatures that state their meaning, and an audit trail that cannot be edited or deleted.
21 CFR Part 11See how it works
One price per user, every module included
Full Access users cost €57.50 per month and Lite users €17.25, billed monthly without a long-term contract. Annual billing lowers the rate. All seven modules are included and there is no implementation fee.
Start with a 14-day free trial. No credit card required.
Regulations and standards in scope
What QFacts does not replace
Better to know this before your trial than after it.
- Design controls and the design history file. QFacts controls the documents in your DHF, but it has no dedicated design-control module with traceability from requirements to verification.
- Risk management under ISO 14971. Keep your risk management file as controlled documents in QFacts; the risk analyses themselves stay in your own tools.
- Vigilance and UDI reporting. QFacts records complaints and their assessment; reports to EUDAMED or the FDA are filed outside QFacts.
Frequently asked questions
Does QFacts support the FDA QMSR?
Since 2 February 2026 the QMSR incorporates ISO 13485:2016 by reference. QFacts covers the processes mapped on this page: document and record control, competence, complaint handling, nonconformities, CAPA and change control, with electronic signatures and an audit trail. Design controls and risk management stay in your own tools.
Does QFacts meet 21 CFR Part 11?
QFacts provides the technical controls Part 11 expects: unique user accounts, role-based access, electronic signatures that state their meaning, and an audit trail that cannot be edited or deleted. Compliance also depends on how you validate and use the system, so we supply validation-ready document templates to support it.
How much does QFacts cost for a medical device team?
Full Access users cost €57.50 per month. Lite users, who read documents and complete their training, cost €17.25. Annual billing lowers the rate. All seven modules are included and there is no implementation fee.
Can we try QFacts before we buy?
Yes. Sign up for a 14-day free trial with access to all features. No credit card is required, and you can book a walkthrough with our team at any time.
Put QFacts to work for 14 days.
Sign up directly and explore how QFacts connects your documents, training and quality workflows. Start with a process your team knows.