MDSAP Audit Support, for Organisations Going Global on One Audit

One audit can satisfy five regulators. We help you ensure it does.

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One audit replaces five.

Done properly, it's your fastest route into five markets.

MDSAP means one Auditing Organisation can give assurance to regulators across Australia, Brazil, Canada, Japan and the FDA. One audit, one report: sounds like a dream.

But MDSAP isn't a lighter version of a single-country audit. It covers 7 chapters against ISO 13485, plus country-specific requirements layered on top. Nonconformities aren't simple major or minor: they're scored by how directly they affect your QMS, with extra weighting if it's a repeat finding or you've released a nonconforming product.

An initial certification audit covering all 90 applicable tasks can run to around 50 hours. That's probably why MDSAP has mostly stayed the domain of bigger manufacturers. The audit itself is efficient. Getting ready for it isn't.

How we support organisations

Support designed to get you ready for what MDSAP actually involves.

MDSAP Gap Analysis

We assess your QMS against all 7 MDSAP chapters and country-specific requirements, before your Auditing Organisation does.

Audit Scope and Duration Planning

We help you understand task applicability and audit duration, so you know what you're walking into and can plan resource and budget accordingly.

Critical Supplier Audit Support

MDSAP has its own definition of a critical supplier. We help you identify yours and prepare for how they'll be assessed.

Audit Preparation and Mock Audits

We run independent mock audits structured around how MDSAP is actually graded — by direct or indirect QMS impact, not simple major or minor.

Ongoing MDSAP Compliance Support

We support manufacturers already in the programme with surveillance audit preparation and remediation of findings.

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Why choose The Other Consultants?

Independent auditing shaped by real certification experience.

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UKAS-witnessed Lead Auditor

Independent and objective

Certification body and notified body perspective

Over 50 ISO 13485 and MDR audits conducted

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    "Just to let you know that today’s audit on design didn’t raise any CARs...

    they accepted that we had a strong internal audit conducted and that our QMS was working and flagging issues” 

    PRRC of a IIa medical device manufacturer.

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    “Adam is a breath of fresh air when it comes to QARA...

    …he takes the time to understand the needs of a client and communicate effectively. He is not afraid of a challenge and always goes above and beyond to not only ensure optimal results but that the end client "gets it". I highly recommend his services.”

    Karandeep Singh Badwal, The Medical Device Podcast

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    “I have worked with Adam on several projects...

    …relating to Medical Devices his regulatory experience and knowledge are exceptional and always up-to-date in the current climate of regulatory changes.”

    Martin Coles, Operations Director - International Associates

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    “Adam is a highly knowledgeable Medtech professional...

    … who has a passion for the industry and its requirements. Adam hit the ground running supporting my requirements and is always dedicated. Adam brought his background and knowledge as part of a project in Supplier Quality working with critical partners including Six Sigma DMAIC and root cause analysis.”

    QuMatthew Clark, European Supplier Quality Manager - CooperVision

“I've sat on both sides of the audit table: auditing for certification bodies and notified bodies, and helping manufacturers get ready. That's what shapes how I prepare people for MDSAP: not theory, but knowing exactly what an auditor is looking for."

Adam Isaacs Rae, Founder

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Preparing for MDSAP?

If you're scoping it out for the first time or preparing for a surveillance audit, we're here to help.

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