Making Medical
Devices Simple

What does a medical device regulatory consultant actually do?

A medical device regulatory consultant guides you through classification, quality systems, technical documentation and market approval so your product can legally reach patients and customers. That covers everything from building ISO 13485 quality management systems to compiling Clinical Evaluation Reports, running classification and gap analysis, and steering submissions across the UK, EU, US, Australia and beyond. Unlike a lot of regulators, we don't just tell you what you can't do. We help you find the fastest compliant route to market.

Do I need ISO 13485 certification to sell a medical device?

In most markets, yes. ISO 13485 is the internationally recognised quality management standard regulators expect manufacturers to have in place before a device reaches market. It underpins UK MDR, EU MDR, FDA and TGA requirements alike, and having it in place from the outset makes approval in additional markets much faster later on, since most regulators build their expectations on top of it rather than starting from scratch.

What is a Clinical Evaluation Report (CER) and do I need one?

A Clinical Evaluation Report is the document that demonstrates your device is safe and performs as intended, using clinical data, literature review and risk analysis, and it's required for almost any medical device placed on the UK or EU market. The depth needed depends on your device's classification and novelty. A well-established Class I product needs far less evidence than a new, higher-risk design.

How is a medical device classified and why does it matter?

Classification determines which regulatory route your device has to take, and getting it wrong can mean months of wasted work or a rejected submission later on. Devices are grouped by risk, from low-risk Class I items through to higher-risk implantable or life-sustaining devices, with the exact rules varying slightly by region. It's usually the first thing to establish on any project, because timeline, cost and required evidence all flow from it.

What is biocompatibility testing and does my device need it?

Biocompatibility testing checks that any device material in contact with the body won't cause harm, and it's required for almost every device with patient contact, guided by the ISO 10993 series of standards. What needs testing depends on the type and duration of contact and the materials used, so a one-size-fits-all test plan rarely fits. The right scope is worked out from the device's actual design, not a generic checklist.

How much does medical device regulatory consultancy cost, and how long does it take?

Cost and timeline depend on your device's classification, target markets and how complete your existing documentation is. A low-risk Class I device is a very different job to a Class III implant launching across several regions. We scope every project against your actual device and goals rather than a generic package, and with 80+ years of combined team experience we're usually able to flag the fastest realistic route early, so you're not paying for guesswork.

Do you review marketing claims, social media, paid ads and influencer content, not just your technical documentation?

Yes. Device claims compliance doesn't stop at the label, so we review marketing wherever it appears, including your website, social media, paid advertising and influencer or affiliate content, since regulators and advertising bodies treat all of these as regulated marketing. It's often overlooked material like a website claim or a paid ad headline that creates risk, even when the technical file itself is solid.

Do you monitor for upcoming regulatory changes, or just handle one-off compliance projects?

Yes, horizon scanning is part of our ongoing support. We track upcoming changes to UK MDR, EU MDR and other regional requirements across the markets you sell in, so you hear about a change that affects your device before it becomes a compliance problem, rather than finding out after the fact. It's built into our ongoing compliance service rather than something you need to ask for separately.

What trade associations is Taylored Consultancy a member of?

We're members of PAGB, the trade association for the UK consumer healthcare industry, which represents OTC medicines, self-care medical devices and food supplements. That connection keeps us close to how device regulation and enforcement priorities are actually developing, which feeds directly into the advice we give clients.

Still have questions? Contact us and we'll be happy to help.