What type of regulatory support do you actually need? How do you work out who to request quotes from, and who to contract with?
To choose a medical device regulatory consultant, match them to your specific market, device type and stage. Insist on the track record of the individual who will actually do your work, and get the scope and deliverables in writing before you commit. Any guarantee of a specific regulatory outcome is generally a red flag, as regulatory advisors should balance risk and uncertainty. The right consultant is the one whose real experience lines up with your project.
Full disclosure: I run a regulatory consultancy, Brightbark Cranberry. Whilst I have an interest in this question, I want you to be informed in your search for a regulatory consultant. I wouldn’t want to take on work that is not the right fit either.
Independent consultant, consultancy, or contractor?
The first question to ask yourself is: what kind of support do you need?
A contractor is an individual regulatory professional who works inside your team on a day rate, usually for a defined period: covering a maternity leave, plugging a gap while you recruit, or adding hands to a submission push. You direct the work. You get capacity and continuity for as long as the contract runs, and you take on the management overhead that comes with it.
An independent consultant works on defined pieces of work from outside your team — a gap assessment, a clinical evaluation, a strategy for a new market. You buy judgement and output rather than hours, and you know exactly who is doing the work. The trade is continuity. If that person is unavailable, the work pauses until they are back, so ask up front how they handle it.
A large consultancy brings a bench: several people, project management, and someone to step in if the lead is ill or leaves. That resilience costs more, and it carries risks of miscommunication when handing off work. The name that sold you the work may well be a different name from the one on your file.
So which is right? It depends on what you are actually buying. If you need hours, hire a contractor. If you need a specific piece of expertise applied to a specific decision, an independent consultant is usually the sharper tool. If you need a programme run across several markets and projects at once, with cover built in, a larger consultancy is the safer choice.
What should a regulatory consultant actually do for you?
A good regulatory consultant does more than fill in forms. They translate the regulations into decisions you can act on — which market to enter and in what order, which conformity assessment route your device takes (the procedure by which you demonstrate that it meets the regulation, and whether an independent certifier has to be involved), what clinical evidence you need, what an assessor at a notified body will expect to see — and they do it in a way that protects your time to market and your budget.
A notified body, if the term is new to you, is the independent organisation that certifies most devices for the EU market; the UK equivalent is an approved body.
Regulatory work done well is a commercial advantage, not a compliance tax: fewer review rounds, fewer surprises, a faster path to selling. The consultant's job is to buy you that advantage, not just to keep you compliant.
The flip side: a consultant cannot want your outcome more than you do, and cannot own decisions that are yours to make. Be wary of anyone who offers to take the whole thing off your hands with no involvement from you. The good ones make you more capable, not more dependent.
The criteria that matter
Here is the checklist I would use.
- Relevant experience for your market. EU MDR (Regulation (EU) 2017/745), the UK route under the Medical Devices Regulations 2002 and UKCA marking, and the US FDA system are different skill sets. Someone excellent at FDA 510(k) submissions (the most common US route to market) is not automatically the right person for an EU technical file (the body of documentation that demonstrates a device meets the regulation). Ask specifically about the market you are entering.
- Depth in your device type and risk class. An implantable orthopaedic device, a dental appliance, an in-vitro diagnostic and a piece of software raise different questions. They have different requirements and standards. Ask what they have worked on that resembles yours, and at what risk class.
- Who will actually do the work. Large consultancies sell you the brand; you want the CV of the person who will hold your file. Ask who the lead consultant is, and whether the work will be done by them or handed to junior staff you have not met.
- How they think, not just what they know. Ask their view on a current piece of guidance relevant to your device — an MDCG document, say (the Medical Device Coordination Group is the EU-level group that publishes guidance on how the MDR is meant to be applied). You are listening for judgement, and for honest uncertainty where the guidance is unclear. A recital of the document tells you nothing. The regulations are full of grey areas; you want someone who can reason in them.
- Scope in writing. A clear statement of work — what they will deliver, by when, and what it costs — this protects both sides.
- Independence and conflicts. Ask whether anything about their other work or affiliations could pull against your interests, and how they handle it.
- Capacity and continuity. Can they cover your timeline? And if the named person is ill, on holiday, or leaves — what happens to your project? A solo consultant and a large firm answer this very differently; neither answer is wrong, but you need to know it.
Red flags
- A guaranteed outcome. "We'll get you CE marked by Q3." No one can promise a regulatory result; the decision belongs to the notified body or the regulator. The job of internal regulatory affairs teams or external consultants is to best prepare your organisation for regulatory interactions, reducing risk and increasing confidence.
- Vagueness about your device or pathway. If they cannot speak specifically to your device type and route after you have explained it, they may be reaching outside their depth.
- Won't put scope in writing. Get deliverables and boundaries into a document. Trust is for the working relationship; it is a poor substitute for a scope.
- Silent hand-off to juniors. There is nothing wrong with a team — but plenty wrong with being sold the senior name and delivered by the trainee without being told.
- No explanation of “this is outside our expertise”. The regulatory world is complex. Skills are built in particular device types and jurisdictions. I would be cautious of a consultant that claims to be an expert for every device type in every market.
When a boutique consultant like mine is the wrong choice
Since I have asked you to trust my advice, here is where it points away from a firm like mine.
If you are running a large, multi-market programme — launching across the EU, UK, US and Asia at once, on a tight coordinated timeline — you may need the scale, project management and standing capacity of a big consultancy or a full in-house team, not an independent consultant. If you need round-the-clock coverage or a deep bench so that no one person is a single point of failure, size matters, and a small firm cannot match it.
Application of regulatory skills and experience is selective, depending on the technical depth of the request. My deep expertise has with non-active (that means not electronic) devices, both implantable and non-implantable. My career is been spent on orthopaedic and dental devices, but the technical and regulatory skills I have built can be applied to a wide range of non-active devices. In these technical areas, I will gladly dive right into the technical detail of a project - through design, manufacturing and testing complexities.
I can still apply my regulatory skills and experience outside of the above scope though, for projects requiring less technical depth, or where another professional is available to augment my skillset. Whether I am willing to take on your project depends on a lot of specific detail, and I will take the time to meet and understand your devices and project to determine this.
The following areas are outside of my expertise:
- In-vitro diagnostic devices.
- Active implantable devices.
- High risk active non-implantable devices.
- High risk software devices.
- Devices in which the final device incorporates animal or human tissue.
More detail about my general and specialist capabilities is available here.
Where notified-body experience helps
I spent nearly seven years as a technical specialist at a notified body, assessing orthopaedic and dental devices, before moving into consulting. I performed audits of technical documentation for high risk implantable devices, including clinical evaluation. The obvious application of that experience is submission-facing work: writing technical documentation and clinical evaluations that hold up (the documented appraisal of clinical evidence showing a device is safe and performs as claimed), and answering notified-body deficiency questions (the written questions a notified body sends back when your documentation does not yet satisfy the assessor), because I have sat on the other side of the table and know what an assessor is actually looking for.
The less obvious application is strategy. Having experience also working in the design, testing and manufacture of medical devices, I can bring a holistic experience to advise you how to get from where you are, to being on the market, whilst avoiding typical issues.
Does hiring an ex-assessor create a conflict of interest?
The short answer is that the impartiality rules in the EU MDR bind the notified body and its staff, and they are written for people moving into a notified body. EU MDR Annex VII prohibits a notified body and its assessment personnel from providing consultancy to the manufacturers they assess, and it requires anyone who consulted for a client before joining a notified body to stay off that client's assessments for three years. Nothing in it stops someone who has left a notified body from advising manufacturers.
Frequently asked questions
Do I need a regulatory consultant with notified body experience?
It helps most for submission-facing work — technical files, clinical evaluations, and responding to deficiency questions — where knowing what an assessor looks for is a real advantage. It matters less for QMS implementation or US-only work. Treat it as one criterion among several.
What questions should I ask before hiring a regulatory consultant?
Ask what comparable devices and markets they have handled, who will actually do your work, how they would approach your situation, their view on a relevant guidance document, and what they would put in a written statement of work.
What are the red flags when choosing a regulatory consultant?
Guarantees of a regulatory outcome, vagueness about your device or pathway, unwillingness to put scope in writing, quietly handing your work to junior staff, and claiming to do everything for everyone. Honest consultants have limits and will name them.
How do I know if a consultant is the right fit for my device?
Match their real experience to your market (EU MDR, UK/UKCA, or FDA), your device type and risk class, and your stage. A strong fit for a Class III implant is not automatically a strong fit for software or an IVD. Ask directly, and expect a straight answer about where they are not the right choice.
If you are weighing up regulatory support and want a straight answer on whether your need matches what I do, I am happy to have that conversation — and if it turns out Brightbark Cranberry is not the right fit, I will tell you so and point you toward the kind of firm that is. You can see how I think about fit on why choose us, read more about the regulatory affairs work I take on, or just get in touch.