The market launch of innovative medical devices is challenging for start-ups: there are countless regulatory requirements and high quality standards that must be met. Product development often ends up taking a back seat.
We understand the specific challenges you face as a start-up. As a legal manufacturer, we handle the registration or licensing of your medical device as the situation requires, to ensure a fast, efficient, and safe market entry in the EU and Switzerland. We document the required information simply and transparently with our artifact-based quality management system. After the successful market launch, we support you with the marketing, further development, and opening up of new markets to ensure the long-term success of your product.
Our goal is to enable rapid and cost-effective market entry while ensuring patient safety at all times. So you can focus on developing medical innovations.
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OUR SERVICES FOR START-UPS
The registration of medical devices is a crucial step on the way to market launch. We handle this task for you in Switzerland and the EU and act as your CH-REP representative.
We guide you through the entire approval process. We enable rapid certification with our quality management system (QMS).
We provide you with comprehensive advice on all topics relating to the development of medical and pharmaceutical products. This includes the creation of technical documentation, the qualification and validation of systems or the creation of procedures and work instructions.
Our network
Contacts open up extraordinary opportunities. Network with experts from the healthcare and life sciences industry, as well as with scientists, manufacturers, suppliers, and financing partners. Take advantage of exclusive access to expertise, build partnerships, find suitable financing opportunities, benefit from innovative technologies, and form strategic collaborations.