Free ISO 13485:2016 Gap Check · 5 minutes · Instant report
How ready is your medical device QMS for ISO 13485?
Answer 17 expert-built questions on the requirements notified bodies and auditors test on every visit — device files, design controls, process validation, traceability and vigilance — and get an instant scored report with priority actions.
Built by the consulting team behind 8,100+ client engagements in 60+ countries — lead auditor–qualified (BSI, TÜV SÜD). High-level screening, not an audit; your report appears instantly on screen.
Answer honestly — the report is only as useful as the inputs. Critical requirements are marked with a red edge.
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GAP CHECK REPORT
Readiness by area
What this means
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Disclaimer. This complimentary gap check is a high-level self-assessment provided for general information only. It is not an audit, a certification decision or recommendation, and it does not constitute technical, professional, legal, financial or regulatory advice for your specific situation. Results are generated solely from the answers you provide and no consultant–client relationship is created by using this tool. Sterling International Consulting makes no warranty, express or implied, as to the accuracy, completeness or fitness for purpose of the output, and accepts no liability for any loss, damage, cost or decision arising from use of, or reliance on, this tool or its report. Clause references summarise requirement intent and do not reproduce the text of any standard. © 2026 Sterling International Consulting. All rights reserved. · www.iso-certification.ph · www.sterling-grc.com