Take our free 20-question self-assessment to find out whether your medical-device quality system would pass an inspection today — and where you may be exposed.
Whether you’re seeking initial certification or preparing for surveillance, this quick scorecard reveals how aligned your systems are with ISO 13485:2016 and regulatory expectations (TGA, MDSAP, EU MDR). Identify weak spots before your auditor does.
What You'll Learn:
How strong your documentation and design-control systems really are
Whether your risk-management and CAPA programs meet ISO 14971 and 13485 requirements
How confident your team would be under audit questioning
Next steps to achieve and maintain certification with less stress
