We make your medical device compliant with EU regulations
We support US medical technology companies entering the European market – from the initial analysis of user needs to successful implementation. With a clearly structured approach, we reduce complexity and accelerate the path to approval under the EU MDR / IVDR.
EU market entry has been decided – now it’s all about the right implementation
The real challenge begins with the decision for the European market: implementation. Requirements differ not only in terms of regulation, but also in the context of use and possibly also in the product. An approach that takes these differences into account at an early stage is now crucial. Accordingly, many companies are asking themselves similar questions:
- Is our existing FDA documentation also sufficient for the EU MDR?
- Do I need a summative evaluation even though my product is already on the market in the USA?
- How do we need to restructure our documents so that they meet all requirements?
- We want to conduct user studies in the EU, but do we have access to the right users and realistic test environments?
- Do we have to adapt our user interface, the IFU or work processes for the EU market?
- Are the user groups similar to those in the USA or do they differ fundamentally (e.g. education)?
We can help you answer these and many other questions.
How we bring your product safely into the EU
01. Gap Analysis – Clarity about the need for action
We analyze your existing data, studies and documents with regard to the EU MDR. This allows us to identify specific gaps and derive concrete next steps for your EU market entry.
02 Implementation – Targeted adaptation for the EU MDR
Based on the analysis, we implement the necessary measures – from formative and summative usability studies to adjustments of the user interface and the IFU to the revision of the documentation.
03. Admission – Accompaniment through the MDR process
We guide you through the MDR process – including preparation for audits. In this way, we ensure that nothing stands in the way of your CE mark.
Certified for excellence
Why Custom Medical?
An integrated team instead of several service providers: We offer you regulatory consulting & implementation, user interface, product & IFU design, formative & summative evaluations as well as software development. This allows you to avoid coordination efforts and typical communication issues.
US & EU company setup: We are represented by affiliated companies in the USA and Germany. You can commission your project via a US company with a US contact person and implement it in Europe at the same time – without additional hurdles in purchasing and cooperation.
Award-winning design: If we work in design, you can be sure that you are working with the best. Among other, we have won 6 RedDots and 2 German Design Awards in recent years.
We have already supported over 400 medical devices/IVDs: We have accompanied numerous products of all classes and continuously conduct usability studies (e.g. about one summative evaluation per week). This experience helps to avoid typical errors at an early stage.
Usability studies in real European usage contexts: We recruit healthcare professionals and patients in Europe & USA and conduct studies in our own laboratories – including operating room environments, doctor’s offices and home environments.
Certified quality: With quality management in accordance with ISO 13485 and information security management in accordance with ISO 27001, we meet the requirements of modern MedTech projects.
Highest customer satisfaction: We survey customer satisfaction after every project and have an NPS of 86 (as of 2025).
What do our customers say about us?
Priscila Panigoro | Regulatory Affairs @Aero Pump
We want to get to know you and your product!
