With over 30 years of collective industry experience, the Casus Consulting team has represented thousands of manufacturers throughout Europe, Latin America, Asia, and the U.S. We have managed large consulting and project management teams and have successfully overseen hundreds of medical device submissions, giving us the expertise to provide clear, pragmatic guidance to manufacturers as they navigate the European market.
We provide the consulting services you need to enter the market in the EU, United Kingdom, and Switzerland. This includes CE Marking to the MDR / IVDR, UKCA Marking, drafting Clinical Evaluation Reports, and more.
We are a European Authorized Representative, UK Responsible Person, and Swiss Authorized Representative for medical devices, including software, implantable, IVDs, custom-made devices, and more.
Casus has a wealth of experience providing tailored solutions to address the unique regulatory needs for a number of clients, including Overjet, Onyx Healthcare, Picterus AS, Phantom Laboratory, and YouSeq Ltd.
Helping you navigate regulatory processes to ensure compliant innovation.
We believe in fostering lasting relationships with our clients. We work collaboratively to ensure your devices meet regulatory requirements and remain available to provide guidance over the long-term.
Our clients never pay arbitrary fees. We are straightforward in our communication, pricing, and timing so that you can feel comfortable reaching out at any time without fear of being nickeled and dimed.
As a specialized firm that focuses on a high level of service quality, we are able to provide director-level personnel as a single point of contact to ensure that you receive the full benefit of our extensive knowledge and experience.
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Our collective track record serves as a testament to our ability to navigate the complex regulatory landscape.
We’re committed to the highest standards of regulatory compliance.
Interested in exploring how our expertise and personalized approach can benefit your medical device business?
Connect with our team to learn more.