Our Services
Every medical device has a story. Our job is to make sure the evidence tells it honestly, completely, and in a way that stands up to the most rigorous scrutiny. We work across the full arc of device development.
From the first question to the last submission and beyond. Boutique, flexible, and with one foot firmly in the commercial world as well as the scientific one.
We don’t use templates or apply generic methodologies. We apply real-world experience of what actually works.
What We Offer
-
The decisions that determine whether your device succeeds are made long before any data is collected. We help you ask the right questions from the outset. What does your device need to prove, to whom, and by what standard? We specialise in constructing both preclinical and clinical evidence strategies, establishing clear benchmarks against the state-of-the-art and designing the specific data gathering programme your device requires. Starting here, rather than at the end, changes everything.
-
Good evidence is not evidence that supports you. It is evidence that is true. We work with manufacturers to design and oversee clinical investigations that are rigorous, objective, and true to the null hypothesis. We follow the data wherever it leads, including when the results are inconvenient. Wherever possible, we run evidence-gathering workstreams in parallel, because the quality of the submission and the speed of getting there are not competing priorities. They are both our problem.
-
The documentation is the record of your proof, not the proof itself. We build Technical Documentation that reflects genuine understanding of the device, its evidence base, and its place in the clinical landscape. No retrofitting. No papering over gaps. We engage directly with regulators and notified bodies and, when regulatory risk becomes a business risk, we work at board level to make sure the implications are properly understood.
-
Getting to market is not the finish line. The evidence life of your device continues through every stage of its commercial existence. We help manufacturers build post-market strategies that are genuinely useful: not just compliant on paper, but meaningful in practice. That means surveillance systems that actually tell you something, and a plan for what to do when they do.
-
For early-stage companies, regulatory strategy does not exist in isolation. It sits alongside funding milestones, investor requirements, IP agreements, and the broader journey from research proof-of-concept to commercially viable product. We work with founders and leadership teams on the governance and business planning that underpins the regulatory work. We ensure that clinical ambition translates into something an investor, a board, or a funding body can understand and support. If the device is not yet on the market, we treat it like the research project it still is.
Not sure where to start?
Most of our clients come to us at a specific moment of need. Some are at the very beginning. Some are mid-development and have realised something isn’t working, and some are further along than they should be without the right foundations in place. Wherever you are, do get in touch. The first conversation is always worth having.
-
It is never too soon. In fact, the earlier we have this conversation, the more useful we can be. The decisions that are hardest to unpick later, about study design, evidence standards, clinical claims and so on, are the ones made earliest, often before anyone has thought to ask whether they are the right decisions. If your device is still closer to a research project than a product, that is exactly when we want to be involved.
-
Almost certainly, yes. And you are not alone. This is one of the most common conversations we have. Sometimes the problem is a gap in the evidence. Sometimes it’s a study that didn't deliver what was hoped. Sometimes it’s a submission that has come back with questions that are harder to answer than expected. We will tell you honestly what we think the problem is, which may not be what you have been told so far. That conversation might be uncomfortable, but it’s always worth having.
-
Alongside them, not instead of them. We work with internal teams regularly. Sometimes we’re an extension of capacity, sometimes we’re an independent perspective on work that needs a fresh pair of eyes, and sometimes we’re a specialist brought in for a specific stage. We’re not interested in taking over, but we are interested in making sure the job gets done well.
-
The answer positions the boutique angle perfectly. We work flexibly, because we know that device development rarely runs to a neat budget or a predictable timeline. We do not have a standardised price list, because no two clients have the same needs. What we can tell you is that the cost of getting the evidence strategy wrong, and having to unpick it later, is always higher than the cost of getting it right from the start. Get in touch and we will have an honest conversation about what you need and what that looks like.
-
We have worked across a wide range of device types and clinical areas. We do not need to be the world's leading expert in your technology, that is your job. Our job is to understand the evidence landscape around it, the standards that apply to it, and what the data needs to show. That combination travels well across specialisms.
-
That is worth talking about. Not all consultancies work the same way, and not all relationships are the right fit. We would rather have an honest conversation about what went wrong before we start than discover six months in that we are repeating the same mistakes with a different letterhead.
-
We work across the UK, Europe, the United States and the Gulf region. Whether you are targeting a single market or planning for international expansion, we can help you navigate the regulatory and evidence requirements.
-
Medical devices and IVDs, across risk classes. This includes active, non-active and implantable devices, medical device software, and molecular diagnostic tests.
Our particular depth is in high risk, novel and first-to-market products, where the evidence will be challenged, the path is not clear and getting it wrong is not an option.