Five steps to get ready
1. Reduce complexity where you can
When developing your product, you can get relevant and solid feedback on your solution in a simulated pre-clinical environment. It's much cheaper and more efficient than running a live test in the health care service. Have you considered the least complex step that still meets your project's need for user involvement? Many Nordic Proof partners have simulation labs, living labs, and pre-clinical environments dedicated to testing. In the simulation labs, you can gather user data together with clinical personnel in a low-risk, highly controlled setting equipped with usability tools such as audio and video recording.
2. Clearly describe the intended use for your product
Give a clear description of the intended use of the solution you want to test — who it's for, in what setting, and the problem it solves. Include your hypothesis for the value it creates: what outcome or benefit you expect it to deliver for the end user. A well-defined intended use matters on two fronts. For our partners, it's essential for assessing your inquiry and matching you with the right test environment and expertice. For you, it's the foundation for determining your product's risk classification — which in turn shapes how the product can be used, and the value it will create for the health service once it's fully developed and ready for implementation. Getting this clear early keeps the rest of your development path aligned with real-world use.
3. Regulatory requirements
Have you properly assessed the MDR requirements for your solution, and taken the necessary steps around data privacy, ethical considerations, and regulatory compliance? Before testing, make sure you've assessed the regulatory requirements that apply to your solution. Under the EU Medical Device Regulation (MDR), devices are classified by risk into Class I, IIa, IIb, and III, based on their intended purpose, degree of invasiveness, duration of contact, and whether they're active or software-based. Classification determines your conformity assessment pathway, the level of clinical evidence you'll need, and whether a Notified Body must be involved. Getting it right early prevents costly delays later in the process. Alongside classification, make sure you've taken the necessary steps around data privacy (GDPR), ethical approvals, and broader regulatory compliance. If your solution uses AI, note that a further layer applies: an AI-based medical device may be designated high-risk under the EU AI Act, which triggers compliance obligations that run in parallel with the MDR technical file — so it's worth mapping both frameworks together from the start. If you're an international company based outside Europe, this step deserves extra attention. Regulatory frameworks such as the EU MDR can differ significantly from those in your home market, including in how devices are classified and what clinical evidence is expected.
4. Prepare a test protocol
If you're aiming to run a pilot or clinical investigation, the test environment will need a test protocol as a starting point. The protocol sets out what you're testing, your hypothesis, how the test will be run, who's involved, what data you'll collect, and how success will be measured. Having a solid draft ready ahead of your first meeting makes a strong, professional first impression — and helps our partners assess quickly how they can support you. For a pre-clinical test, a test protocol isn't required, but it's recommended to have a clear view on the areas mentioned above. A good protocol doesn't need to be perfect at this stage, but it should show that you've thought through your objectives and how a test would realistically work in a clinical or pre-clinical setting.
5. Consider funding and collaboration form
It's worth addressing funding and the nature of the partnership early — doing so creates predictability for both sides. Start with a simple question: do you have the funding in place to carry out the testing, or will you need to apply for support to cover all or part of a test programme? If you'd like a Nordic Proof partner to contribute to a funding application, it's important to clarify upfront whether this points toward a short-term engagement or a longer-term collaboration with the partner as a development partner. This shapes expectations on both sides from the outset. The network offers a dedicated service for project applications and project partnerships. As a general rule, all collaborations through Nordic Proof carry a service fee. There are various national and international funding instruments you can draw on to support testing. National schemes vary from country to country — your national innovation agency (for example, Innovation Norway, Business Finland, Vinnova in Sweden, or Innovation Fund Denmark) is a good place to start. On the international side, Horizon Europe, the European Innovation Council (EIC), and EIT Health are all worth investigating.
Resources
Resources to help you prepare
Phase overview
Understand the typical journey from concept to post-market validation.
Requirements checklist
A practical checklist of what you need to have ready before starting a testing project.
Ethics and privacy basics
An introduction to REK, GDPR, and other compliance considerations in Nordic clinical settings.
How to develop a protocol
Example protocol outline.
Get a overview of our partners
Services
Nordic Proof helps you get started with testing and studies to progress all phases of your development.
