Get the regulatory strategy right, before it costs you a redesign.
For medical device companies working out their route to market. We settle qualification, classification and evidence requirements early, so you're not the company that finds out six months in that you built for the wrong route.
Wrong classification.
Wrong everything after it.
Most of the regulatory pain we see didn't start in the audit room, or with a notified body query. It started months earlier, in a classification call nobody double-checked.
By the time it surfaces, the design is locked in, the evidence has been built around the wrong assumption, and "fixing it" means going backwards.
The Solution
How we stop you building for the wrong route
Three things we do on every engagement, whatever the device or the market.
01
We start with where you want to end up
Then work back to the fastest route that'll actually hold up, for your product and your timeline.
02
You can trace every decision back to a rule
Each one is tied to the rule behind it, so it stands up when a notified body or the FDA asks why.
03
If a route won't hold up, we'll say so straight away
Before you've spent time or money building around it, not after.
The Process
How we turn your product into a route you can build for
It starts with properly understanding what you've got...
Your product
What it is, what it does, and what you're claiming it does. That's what actually determines classification, not what it looks like.
Your markets
UK, EU, US, or all three. Each one runs its own rules and its own timeline, and we plan for that from day one.
Your objectives
The launch window, the funding milestone, the investor deadline that's actually driving this. The strategy gets sequenced around it.
Your starting point
What it is, what it does, and what you're claiming it does. That's what actually determines classification, not what it looks like.
... and then we map a defensible route, whatever the device.
STEP 1
Qualify
We work out what your product actually is in regulatory terms: a medical device, an IVD, or out of scope entirely. Decided by what it's for, not what it resembles.
STEP 2
Classify
We place it in the right risk class against the rules that actually apply: MDR, UK MDR, IVDR, or FDA. Software gets its own logic under Rule 11.
STEP 3
Route
That classification decides your route: notified body involvement, or self-declaration. In the US, that's 510(k), De Novo, or PMA.
STEP 4
Evidence
We map out exactly what you need to prove: pre-clinical testing, clinical evidence, and evidence behind every claim you're making.
STEP 5
Sequence
We put it all in order: what happens first, what depends on what, and the fastest defensible path to your first market, then the next.
The Process
This is a conversation, not a report that lands in your inbox
This isn't work we do at you. It's work we do with you, from the first workshop to the final document.
What it looks like
We run structured workshops with you and your team, in person or online, and think through the classification calls together rather than emailing you a draft to react to cold.
Every key decision gets agreed as we go, so by the time the strategy's finished, you've lived with it, not just read it. And, of course, everything you share with us stays confidential.
What we ask in return
A decision-maker in the room who can make the commercial calls. Straight answers about what you're actually claiming, not the safest-sounding version.
And if the product or the plan changes along the way, we'll stop and re-scope with you, rather than quietly pressing on with a strategy that's stopped fitting.
The Deliverable
What you get
A written strategy covering qualification, classification and the route to market for every target country. Each call backed by the rule behind it, so it holds up with a notified body or the FDA. Assumptions and open questions flagged, not buried. It's a living document: revisited as the product and the regulations move.
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
“I've watched good products stall for months because a classification call got made too early, by someone who wasn't in the room for the audit that followed it. Getting it right at the start isn't extra work. It's the work."
Adam Isaacs Rae, Founder
Ready to get the route right?
Tell us about the product and where it's headed. We'll tell you what it actually takes to get there.