Casus Consulting can help you in Europe, the UK and Switzerland

Locations in Europe, the UK, Switzerland, Australia, and the USA.

How Casus

Discover

Can Help

We are dedicated to building relationships with our clients. By working collaboratively, we ensure your medical devices meet regulatory standards.

Partnership

Transparency

Our approach is straightforward: no hidden fees or surprises. We're transparent about our pricing, communication, and timelines.

Expertise

We don’t delegate your service to junior staff; you’ll always have access to experienced personnel, ensuring quality guidance.

Responsiveness

We pride ourselves on offering high-quality, prompt service. Our timeframe to reply to client inquiries is typically within 1-2 business days.

In-country
representation

EU Authorized Representative
UK Responsible Person

Casus UKRP Ltd.

Casus Europe B.V.

Swiss Authorized Representative

Casus Switzerland GmbH

Regulatory Updates Timely. Clear.

Knowledge Center Informative. Instructive.

Tools & Templates Free. Easy to use.

Regulations Regs & Guidance. Kept Current.

Resources

“

Timothy Dondlinger

COO, Imaging Diagnostics

"Working with Casus Consulting has been an excellent experience. Their extensive assistance has proven invaluable to our organization.

I have been continually impressed with their regulatory knowledge and expertise, both in terms of understanding and interpretation of the regulations themselves, as well as their experience in real-world application of those regulations. I recommend them without hesitation."

COO, Imaging Diagnostics

Beate Pececnik

“

CEO and Head of QMS, Polident

"Polident sells its products to more than 60 countries and therefore we have to take care for many different registrations. Consequently we collaborate with many different consulting companies to cover all requirements. We can say that our collaboration with Casus Consulting was above all expectations and for sure one of our best experiences.

In the middle of October we sent over required documents and at the end of the same month we received the report on document review. We had to settle a few additional requirements and Casus Consulting guided us all the time. In November we sold our first products to the Swiss market. I think no more words are needed…”

“

David SIRET

CTO & CO-founder, DAMAE Medical

“We have chosen Casus Consulting to help us in the MHRA registration of our CE-marked medical device and to represent the company as the UK Responsible Person. The guidelines were very clear, the services timely and efficient. We had time constraints with a UK customer that wanted to purchase our device, they managed to complete the full process and get the MHRA approval within 2 weeks.

We highly recommend Casus Consulting to support in the UK system management.”

What our
Clients say

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Swissmedic Publishes New Manufacturer Incident Report (MIR) Form and Guidance Document

Swissmedic published an updated Swiss Manufacturer Incident Report (MIR) form, to align with the EU’s new MIR PDF Form v7.3.1, and guidance document. Find the details here.

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EC Publishes Updated Manufacturer Incident Report (MIR) Form Version 7.3.1

The EU Commission published a revised Manufacturer Incident Report (MIR) form. The new version (7.3.1) includes sections applicable under the MDR/IVDR and for legacy devices. Find out more here.

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April “In All Other News”: Master UDI-DI Date Postponed, IVD Q&A Progress, and More

Collection of April 2025 updates not already reported on individually: IMDRF Updates, upcoming IVD guidance on distance sales and performance studies, pending UK legislation, and more.

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Swiss Federal Council Taking Steps to Allow US FDA Medical Devices in Switzerland

The Swiss Federal Council published a long-awaited update on the proposal to allow FDA-authorized medical devices in Switzerland. Click here for more.

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Team NB MDR Clinical Evaluation Training: Aug 27, 2025 EU Afternoon, US Early Morning

Team NB is offering a virtual training on MDR clinical requirements. It is targeted toward those with previous experience creating clinical evaluations, and will focus on real case examples. Find out the full details here.