Know your route to market before you spend the money.
The Regulatory Strategy Report is a fixed-price consulting service for medical device start-ups, spin-outs and companies new to medical device regulation. It sets out the available and recommended regulatory pathways for your device in your target markets – including the UK, EU and USA – from where you are now to placing your device on the market, and what comes after. It can be delivered remotely to any company in any location, by our former notified body auditor.
Regulatory Affairs ConsultingWhich of these are you?
The ServiceWhat you get
A fixed price for a complete regulatory strategy for your device, written by someone who spent nearly seven years auditing and managing certifications at a leading notified body and approved body. Not only does the text of the legislation matter - the interpretation matters too.
This is a highly tailored service. The report and its recommendations are researched and analysed for your device, in your target markets - and your team learns the regulatory journey without the trial and error.
The service includes a meeting to discuss our findings, recommendations and risks. The report is typically delivered within 2-4 weeks of the agreed start date.
Our price for this service is agreed in advance and fixed - meaning you are not signing up to open-ended consulting fees.
The Regulatory Strategy Report DeliverablesThe recommended route to market in each target market, with the reasoning.
A regulatory roadmap with estimated timelines and costs.
A clinical evidence strategy.
A regulatory risk register.
Optional: a one-page summary for investors.
In DetailThe Report
PathwaysApplicable legislation
Qualification as a medical device
Classification analysis and rationale
Route to market
Dependencies and efficiencies between markets
Registration requirements, including UDI (unique device identification)
OrganisationImpact of company structure and subcontracted activities
Economic operators and in-country representation
Regulator engagement, and choice of notified body (EU) or approved body (UK)
Quality management system strategy, and the PRRC (Person Responsible for Regulatory Compliance)
EvidenceExpected contents of the technical documentation
Clinical evidence strategy
Post-market regulatory requirements
PlanRegulatory roadmap, timelines and estimated costs
Regulatory horizon
Regulatory risk register
Glossary
Optional: one-page summary for investors
ObjectionsWhy Not? Here’s Why.
-
Regulators answer specific questions about how the rules apply, but they do not consult. The MHRA’s advice meetings exclude consultancy and tailored advice on device design, and notified bodies cannot advise at all. Our report is a strategy for your device in your target markets, with a roadmap, costs and risks you keep.
-
Classification is one of nineteen parts of the report. Route to market, economic operators, company structure and clinical evidence all follow from it - and they interact between markets.
-
That’s a common place to start. The report shows how your data fits each route to market, and what else is needed before submission.
-
Early is the cheapest time to change direction. The legal manufacturer, target markets, classification, assessment route and clinical data expectations all need deciding early, because later decisions depend on them.
-
This is a fixed-price service, agreed before we start. For spin-outs, we can discuss alignment of payment with grant cashflow.
-
This is fully covered by our contract. Having previously worked at a notified body, we are used to highly confidential environments and keeping information separate.
What the Regulatory Strategy Report is not.
This is not a single advice meeting - it covers your whole route to market.
This is not a generic report - it is researched and analysed for your device, in your markets.
This is not technical documentation writing - it sets out what you will need.
This is not an open-ended consulting project - it’s a fixed-scope, fixed-price engagement.
This is not a guarantee of classification or approval - it is a highly informed professional opinion.
We cover non-active devices, and lower-complexity active and software devices - we will confirm when you get in touch. We do not provide this service for IVDs (yet!).
OUR PEOPLEJoseph Langley MEng CEng MTOPRA
Design, manufacture, quality and regulatory. Turbocharged with a highly motivated interest in connecting technical and commercial factors.
Get in touch, and we’ll arrange a discovery call at your convenience.
Would you rather plan the route now, or discover it later?
-
In the EU, classification uses the rules in Annex VIII of the MDR, with the relevant MDCG guidance. The UK is similar, but with different rules. The USA uses a list-based classification system.
Classification can be complex, and significantly affects the route to market. We recommend settling it before you begin work on technical documentation.
-
This has become less clear since the implementation of the new EU Regulations. Clinical data is often considered to be the limiting factor. The old view was that, for many devices, the bar for clinical data was lower in the EU, and therefore marketing in the US first was more viable. Some people argue that this has switched since the new EU Regulations.
We argue that it varies significantly between different types of devices, their novelty, risk profile, and intended patient population. This should be considered in detail in the regulatory strategy for the device.
-
It’s never too soon to plan your regulatory journey. Several critical factors need to be decided early, because they shape later decisions and resource commitments: who will be the legal manufacturer, which markets are commercially desirable, the classification of the device in those markets, the assessment routes for that classification, and the clinical data expectations in those markets.
If you have already started - for example, you have completed a clinical investigation - it is not too late.
-
A regulatory strategy sets your route to market early in a project. The MDReady Report checks your finished technical documentation before you submit it to a notified body or approved body.