ISO 13485 Audit Readiness

Get audit-ready for ISO 13485:2016 - the international quality management standard for medical devices - without the guesswork. Continuum ISO 13485 Audit Readiness walks you clause by clause through the standard so you can see exactly where your quality management system stands before an auditor arrives. Rate each requirement as conforming or a gap, attach your supporting evidence directly to each clause, and track nonconformities from open to closed. When you're ready, submit a section - or your whole system - for a written gap analysis prepared by a Continuum Improvement quality expert, so you walk into your certification, surveillance, MDSAP, or notified body assessment knowing exactly where you stand. WHAT YOU GET - Self-assessment against all 72 assessable clauses of ISO 13485:2016 - Attach evidence (procedures, records, certificates) to each requirement - Nonconformity tracker from open to closed - Written expert review: 1 section, 3 sections, or all sections - Conditional clauses (sterile, implantable, installation, servicing) can be marked N/A - Built by Continuum Improvement LLC quality professionals The self-assessment and any review are audit-readiness aids and professional opinions. They are not an ISO 13485 certification and do not guarantee any audit outcome; certification can only be granted by an accredited certification body. This app is not a medical device and does not provide regulatory or legal advice.