The Gap Heatmap is a free self-assessment for SAHPRA-licensed medical device businesses. Answer 15 plain-English questions about your business and see a personalised heatmap — your top audit risks, ranked by severity and mapped to ISO 13485:2016 clauses.
Your results show on this screen the moment you finish. No consultant. No R250,000 quote.
Your data is protected. · ISO 13485:2016 aligned · We score your answers to show your result, and only keep them if you ask us to email your report.
This Gap Heatmap is a self-assessment tool that supports compliance and audit readiness. It is an indicative guide based on the answers you provide — it is not a regulatory determination, audit, or certification, and does not guarantee any SAHPRA outcome. ISO 13485 Compliance OS is not a regulator, certification body, or law firm. Results reflect ISO 13485:2016 clause coverage as commonly assessed and should be verified against your actual quality management system. African-built, international-grade.