Academic researchers
You have a working prototype and the research behind it. We map the route from laboratory invention to a device clinicians can use.
Regulatory pathways for medical devices
We bridge the gap between breakthrough medtech ideas and regulatory compliance, helping academics and innovators bring life-changing medical devices to market safely and efficiently.
Where innovation meets compliance
Breakthrough medical technology often starts in an academic lab or a young spin-out. Regulation is where many of those ideas stall: the frameworks are dense, and getting them wrong early is expensive later.
innoMerge exists to clear that path. We turn regulatory hurdles into a structured plan, so researchers and founders can focus on getting their technology to clinicians and patients.
- Built for academic ventures
- Our work is shaped around university researchers, technology transfer offices and early-stage spin-outs.
- Practical, not bureaucratic
- Plain-English advice and systems sized to your stage, without administrative weight you don't need yet.
- With you end to end
- From first classification through quality systems, technical files and submission.
Who we work with
University spin-outs
Investors expect a credible regulatory plan. We build one that de-risks development and holds up under due diligence.
Digital health and SaMD
Software, AI and machine-learning products follow their own rules. We advise on qualification, classification and IEC 62304.
The route from lab to market
Every medical device passes through the same four stages. We join wherever you are and plan the stages ahead.
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Concept and classification
Confirm whether your invention is a medical device, which class it falls into and which market to enter first. These answers shape every decision that follows.
How we help
- Regulatory strategy and classification
- Grant and funding support
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Design and technical documentation
Build compliance into development instead of retrofitting it. We set up a quality system sized for an early-stage team and compile the technical file as you go.
How we help
- Quality management systems (ISO 13485)
- Technical file and risk management (ISO 14971)
- Clinical evaluation reports
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Conformity assessment
Prepare for review by an Approved Body or a Notified Body. We find the gaps in your file before the assessors do.
How we help
- Gap analysis and pre-audit review
- Submission strategy
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Market access and post-market
Place your device on the market with UKCA or CE marking, and put in place the surveillance that keeps it there.
How we help
- Post-market surveillance planning
- Regulatory mentoring for your team
Services
Not sure which you need? Book a call (opens in a new tab) and we'll work it out together.
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Regulatory strategy and classification
Determine whether your product qualifies as a medical device, SaMD or IVD, and its classification under UK MDR and EU MDR.
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Grant and funding support
Act as your regulatory partner on grant applications, and write the regulatory work packages for funders such as Innovate UK and NIHR.
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Quality management systems
Implement an ISO 13485 quality system that fits an early-stage company, without paperwork you don't need yet.
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Technical file compilation
Hands-on help compiling technical documentation in accordance with the required standards and documents.
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Gap analysis and pre-audit review
Review your research data and documentation to find gaps before a formal Approved Body or Notified Body assessment.
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Mentoring and workshops
Training sessions and one-to-one coaching for academic researchers, grant applicants and startup leaders.
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UK Responsible Person (UKRP)
We act as your UK Responsible Person, so you can place a CE-marked device on the Great Britain market.
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MHRA registration
We can help you to register your device with the Medicines and Healthcare products Regulatory Agency.
Frameworks we work in
The regulations and standards your device will be assessed against, and the ones we know best.
UK MDR 2002
UKCA marking for Great Britain
The UK Medical Devices Regulations 2002, enforced by the MHRA. Most of our clients start here, so we plan the route to the Great Britain market first and keep the EU in view.
EU MDR 2017/745
CE marking for the European Union
We prepare the technical documentation and clinical evidence a Notified Body expects.
UK Responsible Person
UKRP for CE-marked devices
If your device is CE marked as per EU MDR, you are required to have a UKRP to allow you to market your device in the UK. Let us take that burden on for you.
ISO 13485
Quality management
The quality system standard for medical devices. We build one sized for an early-stage team.
ISO 14971
Risk management
From hazard analysis to residual risk, documented the way assessors expect to read it.
IEC 62304
Software lifecycle
The lifecycle requirements for medical device software, including standalone SaMD.
Academic integration
Regulation shouldn't be an afterthought in the journey of innovation. Academics and innovators often struggle because regulation is rarely taught at university, so we're on a mission to build a bridge between the academic and regulatory worlds.
Should regulation be part of academia?
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In your course
Sessions that fit into your existing curriculum, giving students the regulatory knowledge industry expects.
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A workshop at your university
Hosted by us for academics, innovators and founders navigating the complex world of medical devices.
Want to discuss how we can help demystify medical device regulation at your university?
Email us about a workshopMedical device regulation in figures
- Months for a typical EU MDR certification review
- 13–18
- Of that time sits with the manufacturer, not the Notified Body
- 58%
- Years of medical device regulatory experience
- 10+
Sources: European Commission survey of Notified Bodies (data to February 2025); Team-NB survey, 2025.
How we work
- translate.
- We turn dense regulations, standards and guidance into clear actions for your team.
- educate.
- We give founders the regulatory awareness to design compliance in from the start.
- guide.
- We lead you through classification, documentation, clinical evaluation and submission.
- empower.
- We build regulatory capability inside your team, so you can carry it forward without us.
What clients say
“Working with innoMerge/Faiza has been an invaluable experience. The expertise, guidance and support throughout the project have been excellent, helping us navigate complex regulatory requirements with confidence. Bridging the gap between academia and regulation was particularly beneficial as this helped us understand how regulatory considerations underpin successful commercialisation and enables us to make more informed decisions as we develop our innovation.”
“Faiza provided expert guidance and support throughout the de-risking process. She provided clear, practical advice that helped navigate what could otherwise have been a highly complex regulatory pathway.
Faiza consistently went above and beyond to support our project, and I would have no hesitation in recommending innoMerge to organisations seeking expert medical regulatory advice.”
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Talk through your device
Book a call to discuss your device, its stage and the markets you're aiming for. You'll come away knowing your next regulatory step.
- info@innomerge.co.uk
- Based in
- United Kingdom
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