ISO 13485 Audit Readiness — Continuum Improvement LLC
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Email SupportISO 13485 Audit Readiness walks you clause by clause through ISO 13485:2016 — all 72 requirements across clauses 4 to 8 — lets you rate each one, attach supporting evidence, and track nonconformities from your last audit. When you are ready, request a written expert gap analysis before a certification, surveillance, or MDSAP audit, or ahead of a notified body assessment.
Coverage includes the medical device file, design and development files, risk management across realization, purchasing controls, production and process validation, traceability, complaint handling, and reporting to regulatory authorities.
Where do I buy or view the in-app purchases? Tap "Unlock expert review" at the top of the assessment screen — the three credit packs are shown there.
Some clauses do not apply to my device. What do I do? Rate them N/A. ISO 13485 contains requirements that are genuinely conditional — sterile devices, implantable devices, installation, servicing, cleanliness of product, and customer property. The app includes all of them so nothing is missed; marking the ones that do not apply is normal and expected. Sections submit only the items you have rated, so N/A items do not consume review credits.
How do I delete my account and data? Use the in-app account options, or email us and we'll remove your account and its data.
Is my data private? Yes. Your assessment content is stored securely and is never sold or shared. See our Privacy Policy below.
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