ISO 13485 quality system software for medical device manufacturers
Build the ISO 9001 base, add the ISO 13485 requirements, and keep records audit-ready every day. Free readiness assessment included.
Who it is for
For medical device manufacturers and contract manufacturers with 5 to 30 employees, whether you work to ISO 9001:2026 or have no formal system today.
What you get
Document control
Controlled versions, electronic signatures with an audit trail, and three-tier review and approval.
Design and development controls
Design inputs, outputs, reviews, verification, validation and changes in linked records.
Supplier controls
Supplier evaluation, approved supplier list, scorecards and receiving inspection.
CAPA
Nonconformance, AI-assisted root cause analysis, corrective actions and effectiveness review.
Calibration
Equipment schedules, calibration records and out-of-tolerance handling.
Traceability
Lot and serial identity, linked production records and evidence packs.
Internal audit and management review
Audit programs, findings, management review inputs and tracked actions.
Medical device records
UDI, complaint handling and MDR/vigilance workflows, device master records, DHR and technical file templates.
Controlled production
Sterile and cleanroom controls, process validation records and training and competence records.
How it works
- Tell us about your company. Confirm your scope, processes and existing evidence.
- QMS2GO drafts your system. Review procedures and records for the ISO 9001:2026 base and ISO 13485.
- Run and prove it. Use controlled records in daily work and track the evidence for your audit.
Get your free assessment
Your free assessment covers the ISO 9001:2026 base plus the ISO 13485 requirements.
Find the gaps and agree practical next steps. No cost, no obligation.
QMS2GO supports your path to certification by an accredited body. QMS2GO does not certify companies or issue certificates.
ISO 13485 is quoted separately. Request a quote.
Frequently asked questions
Does QMS2GO certify us?
No. An accredited certification body issues ISO 13485 certificates. QMS2GO helps you build, run and prove your quality system.
Do I need ISO 9001 first?
No separate ISO 9001 system is needed. The ISO 9001:2026 base is built in the same system with the ISO 13485 requirements.
What does the free assessment cover?
The free assessment covers your ISO 9001:2026 base plus the ISO 13485 requirements, identifies gaps and helps you prioritize next steps.
How long does setup take?
Setup depends on your scope, existing records and the work your team needs to complete. We agree the setup plan with you after reviewing your company.
Is ISO 13485 included in the flat plans?
ISO 13485 is quoted separately. Request a quote for your company. No validation pack is promised with the software.
More standards in one system
Keep shared quality records together while managing the requirements of each standard.
API Q1 software for manufacturers, API Q2 software.