Casus Consulting Welcome Trusted partner for medical device & IVD Regulatory Affairs and Quality Assurance. With over 15 years of experience in the industry, we bring clear and practical guidance to our clients. Our team has supported hundreds of clients through the process of medical device registration and in-country representation.
 Our Services

Mission &
Core Values Our mission is to provide reliable and principled regulatory affairs consulting for medical device companies. We are committed to fairness in pricing and clear communication. By delivering quality feedback that is both knowledgeable and practical, we aim to prevent unnecessary costs or delays to market entry. Partnership Our commitment doesn't stop once you sign the agreement; we provide long-term guidance and support as the regulatory requirements evolve. Transparency Our approach is straight forward: no hidden or arbitrarily raised fees, and no surprises. We are clear about our pricing, deliverables, and timelines. Responsiveness We know the pain of trying to get ahold of a supplier. We take pride in being prompt and typically reply to requests within 1-2 business days.

Our Services Read Recent Updates EU Authorized Representative UK Responsible Person London, England Steinhausen, Switzerland Swiss Authorized Representative Sydney, Australia Australian Sponsor Texas, USA US Agent Trusted Resource for Regulatory News Our newsletter recipients are comprised of manufacturers like you, but also other industry groups such as: Notified Body employees, Competent Authority personnel, other consulting firms, contract manufacturers, testing labs, distributors, and more.

 Our Offices We offer the below in-country representation services through our fully-owned legal entities. Utrecht, The Netherlands Our newsletter keeps industry informed. Sent monthly.

“ 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

Our Memberships

RAPS Regulatory Affairs Professionals Society More Info TOPRA The Organisation for Professionals in Regulatory Affairs More Info TEAM PRRC Team Person Responsible for Regulatory Compliance More Info

EU Authorized Representative UK Responsible Person Swiss Authorized Representative We can help advise of the requirements, so that you have a clear understanding of how to start selling your devices.
 Ready to get started? Whether you're still in the discovery stage or ready to enter the market, we can help. Send an e-mail