Audit Services

ISO 13485 audits for medical device startups.

Led and signed off by an ASQ Certified Medical Device Auditor (CMDA) with two decades of medical device experience.

Whether you’re preparing for your first certification audit or running an annual internal audit program, depth and speed don’t have to be a trade-off. Fixed scope, transparent pricing, predictable timelines — with capacity for urgent engagements when you need them.

Certifications —
  • ASQ CMDA
  • ASQ CMQ/OE
  • RAPS RAC
  • Securiti AI Governance
i.

Internal Audit Program

Your independent eye, on a steady cadence.

ISO 13485 requires annual internal audits — but doing them well, independently, and on schedule is hard when your team is small or stretched thin. We act as your dedicated internal audit function, with a clear scope and a fixed starting price.

  • Annual audit plan aligned to your QMS scope and risk areas
  • Independent execution, remote or hybrid
  • Findings report with prioritized nonconformities
  • CAPA recommendations and follow-up verification
From $3,500 5 calendar days
ii.

Certification Readiness Assessment

Walk into your registrar audit ready.

Before BSI, TÜV, or your chosen notified body arrives, know exactly where you stand. A focused engagement that maps your current QMS against ISO 13485:2016 clause by clause and gives you a clear path to remediation.

  • Comprehensive document and record review against ISO 13485:2016
  • Sample interviews with key personnel
  • Findings report mapped to clauses, with severity ratings
  • Prioritized remediation roadmap with effort estimates
From $7,000 10 calendar days
Need it faster? Expedited turnaround is available — half the timeline at a 50% premium, subject to capacity. Get in touch to confirm availability.

We use modern AI tools to keep our work efficient — every finding is reviewed and signed off by a certified lead auditor.

Discuss your audit needs →
Frequently Asked

Common questions.

What is the difference between an internal audit and a certification audit?

An internal audit is performed by you (or on your behalf) to verify your QMS is working as intended — it’s a requirement of ISO 13485 Clause 8.2.4 and must happen at planned intervals. A certification audit is performed by an accredited registrar like BSI or TÜV, who decides whether to issue or maintain your ISO 13485 certificate. Internal audits prepare you for certification audits; they don’t replace them.

How much does an ISO 13485 internal audit cost?

Our Internal Audit Program starts at $3,500 for a focused engagement delivered within 5 calendar days. Larger or more complex QMS scopes may run higher; we quote a firm price after a brief scoping call.

How long does an ISO 13485 gap assessment take?

Our Certification Readiness Assessment is delivered within 10 calendar days. If you need it faster, expedited turnaround is available — half the timeline at a 50% premium, subject to capacity.

Can ISO 13485 audits be conducted remotely?

Yes. Most engagements are fully remote, using secure document review and video interviews. Hybrid (remote document review plus an on-site day) is available for clients who prefer it. ISO 13485 explicitly permits remote auditing, and notified bodies have broadly accepted it since 2020.

What does the FDA QMSR transition mean for my company?

As of February 2026, the FDA’s Quality Management System Regulation (QMSR) aligns 21 CFR Part 820 with ISO 13485:2016. For most companies already certified to ISO 13485, the transition is manageable but not automatic — there are still FDA-specific requirements layered on top. A gap assessment is the fastest way to know where you stand.

How do you use AI in the audit process? Is my data secure?

We use modern AI tools to accelerate document analysis and report drafting — work that traditionally took days now takes hours. Every finding is reviewed and signed off by a certified lead auditor; AI never makes audit judgments unsupervised.

All client documents are processed under zero-data-retention configurations or in segregated environments, and we’ll sign your NDA before any work begins.

What deliverables do I receive?

For internal audits: an audit plan, a findings report with prioritized nonconformities, CAPA recommendations, and follow-up verification. For gap assessments: a clause-by-clause findings report mapped to ISO 13485:2016, severity ratings, and a prioritized remediation roadmap with effort estimates. Everything is delivered as editable Word and PDF.

Can you help us remediate the findings?

Yes. Remediation support is available as a separate engagement, quoted based on the scope of work identified. Some clients prefer to remediate internally and use us only for verification — that’s fine too.

Get in touch

Ready to start?

Tell us about your QMS and what you’re preparing for. We’ll get back to you within one business day with a scoping call.

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