The Other Auditors

Independent Medical Device Auditors

The Other Auditors provide objective, risk‑based audits across ISO 13485, ISO 14971, IEC 62304, MDSAP, EU MDR/IVDR and NMPA standards for enterprise‑scale manufacturers.

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Our approach

Staying compliant with complex medical device regulations shouldn’t feel like guesswork.

We operate exclusively as independent external auditors, bridging the gap between overstretched internal teams and traditional consulting firms.

Built on years of real-world auditing experience, our proprietary C.L.E.A.R. audit model — Collect, Learn, Evaluate, Archive, Reflect — gives you a repeatable methodology and clear guidance from pre-audit prep to final report, without the conflicts of interest that come with consultancy work.

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What we offer

Tailored, risk based schedules aligned to ISO 13485 requirements.

Working under a defined purchasing agreement, we deliver objective, in-depth assessments that strengthen your quality systems and regulatory readiness.

Our services cover every stage of compliance, including full-scope ISO and MDSAP audits, technical documentation reviews, supplier and multi-site programmes, and regulatory readiness assessments. We also provide post-audit reporting and back-room support during notified-body inspections to help you respond with clarity and confidence.

Our goal is simple: to ensure that when regulators or notified bodies assess you, you’re fully prepared and solid.

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What our clients say

  • “Adam has recently undertaken some internal audits on our QMS. His experience and knowledge shone through throughout the process, and he has added value to our QMS and the QA department.

    It was fantastic to get a fresh set of eyes on our procedures and he had some fantastic idea for improvements that we are excited to get started on. Adam is great to work with and I’d highly recommend him for any QA/RA auditing.”

    CEO, Surgical instruments medical device manufacturer

  • “Adam is a fantastic person and resource; he came in as a contractor and helped us hugely in preparation for our recertification audit. Offering guidance on how to prepare for an audit whilst auditing our existing systems for what to tighten up on.

    His feedback and report were in-depth but extremely understandable to implement the tweaks required. I'd have no hesitation in having Adam come back in preparation for our next audit.

    Head of Quality, borderline medical device manufacturer

Ready to make your audits simpler and more effective?

We’ll show you how

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