Medical device design and regulatory consultancy with our own workshop near Bristol

We design and prototype medical devices near Bristol, then take them through to a technical file ready for UKCA or CE marking.

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We work with teams funded by Innovate UK and NIHR.

NIHR Logo
Innovate UK Logo

Who we work with

Our clients are medtech startups and SMEs in the UK and Europe, many of them just after a grant such as an Innovate UK or NIHR i4i award. They need a working prototype and a clear route to UKCA or CE marking, without building a full engineering team first.

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"I want to say how much I’ve valued the collaboration over the past few weeks. You've been incredibly responsive, engaged, and clearly invested in the process. Your research even encouraged me to revisit an approach I had previously dismissed, which has added real value to the project. I particularly appreciated how you challenged and interrogated ideas with empathy - never dismissing them outright, but instead exploring how they might work, if not now, then in the future. You’ve also managed expectations thoughtfully, which has helped the development feel both grounded and ambitious."
Antionette
AntionetteFounder
"Working with Rob at MDIN over the last year has been invaluable in getting our product to market. The attention to detail and regulatory knowledge has been fantastic. Highly recommend."
David
DavidProject Manager
“The team at MDIN went above and beyond, always available and deeply knowledgeable about UKCA requirements post-Brexit. They turned our technical file into a polished, compliant package - exactly what we needed to move forward confidently.”
Tom Henderson
Tom HendersonManaging Director

What working with us looks like

A fixed proposal before we start

You get a written proposal with the work plan, timescales and cost before any work begins.

Prototypes made in-house

We run FDM and SLA 3D printers and light fabrication in-house, so most parts are made the same day or overnight.

Test evidence you can use

We build test rigs and run bench tests in-house, including force testing, and write the results up for your technical file.

Your IP stays yours

Everything we create on your project, from CAD to test data, is assigned to you.

Regulatory work alongside the design

Risk management and the technical file are built as the design develops. That’s how the rugged autoinjector went from first concept to EU MDR Article 117.

Help at the stage you're at

We can take on a single piece of work, such as a 1-2 week feasibility sprint or a gap assessment, or run the whole development programme.

Medical Device Design, Development and Regulatory

Services

Concept development

Concept Development

Meeting table with notebook, callipers and MDIN mug in the MDIN meeting room

Feasibility Studies

Design iterations

Design and Development

Formlabs Form 3 and Form 4 resin 3D printers in the MDIN workshop

Rapid Prototyping

Mecmesin MultiTest 2.5-dV motorised force tester on the bench in the MDIN workshop, with a device component in the test fixture

Testing and Validation

Medical Device Regulatory Compliance

Regulatory Compliance

Medical Device Quality Management Systems

Quality Management Systems

Medical Technical file creation & management

Technical File Creation & Management

Warco D250EL lathe in the MDIN workshop

Pre-Production

How a project runs

  1. A free 30-minute call. We talk through the device, where you are now and what the funding covers.
  2. A written proposal. Scope, deliverables, timescales and cost, agreed before we start.
  3. Short build and test loops. You see prototypes and test results at each stage, with the documentation kept up to date as we go.
  4. A handover you can use. CAD, drawings, test reports and technical file content, all assigned to you.

Ready to talk it through?

Book a free 30-minute call at a time that suits you.

Book a free call

Tell us about your device

Happy to sign your NDA, or we can send you ours, before you share any details.

MDIN meeting room with the MDIN sign in the window, at Unit 2e, Hewish, near Weston-super-Mare

Building a non-medical product?

MDIN Design delivers concept, prototyping and manufacturing-ready design for consumer and industrial products.

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