ISO 13485 Compliance OS
OperatingQuality management and compliance software helping medical device makers meet ISO 13485, SAHPRA and FDA QMSR rules.
- Employees
- 2-10
About ISO 13485 Compliance OS
ISO 13485 Compliance OS is a Cape Town-based compliance platform for medical device businesses. It serves SAHPRA-licensed companies in South Africa and also markets to US device makers that must now meet the FDA's Quality Management System Regulation, which builds ISO 13485 into 21 CFR 820.
The software lets teams run their quality management system in one place: clause-by-clause gap analysis, drafting of inspection-ready procedures, mock FDA inspections and ongoing supplier monitoring. It is positioned as a lower-cost alternative to legacy electronic QMS products and is sold through published pricing and booked demos.
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Frequently asked about ISO 13485 Compliance OS
- Where is ISO 13485 Compliance OS based and when was it founded?
- ISO 13485 Compliance OS is headquartered in Cape Town, South Africa and was founded in 2025.
- What sector is ISO 13485 Compliance OS in?
- ISO 13485 Compliance OS operates in SaaS, HealthTech and LegalTech.
