Software as a Medical Device (SaMD) and AI device consultancy
Clinical claims are easy to make. We make sure yours actually hold up.
Your technical file tells a story.
But right now, it's probably telling three.
SaMD and AI devices don't behave like hardware. Intended purpose drifts. Clinical claims end up in IFUs and marketing copy before the evidence has caught up. By the time a technical file reaches a notified body, the intended purpose, the CER and the risk file are frequently describing a variety of slightly different devices.
Notified bodies are scrutinising SaMD and AI technical files more closely than ever. The same problems recur: clinical validation confused with analytical validation, PMCF plans that don't connect to the risk file, and claims the evidence simply doesn't support.
For manufacturers building genuinely innovative software and AI products, getting the regulatory foundations right early is what determines whether the device reaches market at all.
Structured regulatory support, built around how SaMD and AI regulation actually works in practice, is what makes the difference.
How we support organisations
Structured regulatory support at every stage of SaMD and AI device development and compliance.
Regulatory Strategy and Device Classification
We help determine the right classification and regulatory pathway under EU MDR, UK MDR and FDA frameworks.
Clinical Evidence Gap Analysis and Review
Analytical validation and clinical validation are not the same thing. We help you understand what evidence you need.
Notified Body and Approved Body Preparation
We help ensure your technical file holds up before a reviewer finds the gaps.
Technical Documentation Development
We support the preparation and review of SaMD and AI technical documentation: CERs, GSPR checklists and PMS plans.
Post-Market Surveillance and PMCF
For AI devices especially, PMS isn't a box to tick. We help you build systems around your specific residual risks.
Why choose The Other Consultants?
Independent auditing shaped by real certification experience.
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
"The question I get asked most about SaMD is whether a clinical trial is needed. That's usually the wrong starting point. The right question is whether the evidence you have can actually support the claims you're making."
Adam Isaacs Rae, Founder
Developing a SaMD or AI device?
If you're navigating classification, building your clinical evidence strategy or preparing for notified body review, we're here to help.