How will you market your product?
The answer determines whether your product is a medical device and, if so, its risk class. At Eitri, you get the regulatory assessment, tools and support from an experienced adviser to get started on the right track.
A subsidised offer for companies in incubation at Eitri.
From “we need documentation” to a roadmap towards CE marking
Regulatory assessment
Is your product a medical device? What is its risk class, and which requirements apply in the EU and the US?
Documentation and quality management system
Digital tools to help you document correctly from day one, with support to get started.
Strategy towards CE marking
A senior adviser who brings everything together and helps you prioritise.
The modules can be taken separately. Most companies start with Module 1.
Getting started is simple
To use this offer, your company must have an incubation agreement with Eitri.
Get in touch
Briefly describe your product in the form below. Please do not include confidential details.
A conversation about incubation
We discuss the incubation agreement, identify your needs and determine which modules are right for you.
Get started with the Regulatory Starter Package
We coordinate the process and support you on your journey towards CE marking.
How much does it cost? The services are subsidised, so you only pay a contribution towards the cost. We will discuss pricing and terms during our conversation.
This package is designed for companies that
- are in incubation at Eitri and developing a healthcare solution
- are unsure whether their product is a medical device
- are preparing to meet investors and want a regulatory plan to present
- want to get things right from the start without an in-house QA/RA specialist
Not in incubation yet? Get in touch anyway and let’s talk.
Answers to common questions
Do we have to take all three modules?
No. You choose what you need. Most companies start with the regulatory assessment and add other modules once they know more.
How much does it cost?
The services are subsidised, so you only pay a contribution towards the cost. The amount depends on the modules you choose. We will discuss pricing and terms in our first conversation.
Who provides the services?
Experienced regulatory advisers and tool providers. Eitri coordinates the process and supports you throughout.
Tell us briefly what you need
It only takes 2–3 minutes. We will contact you for an initial conversation with no obligation.