From Development to Approval
Whether medical technology, laboratory and analytical technology, or photonics: technical products must comply with standards and regulatory requirements. We support you on the path to obtaining approval – from the early development phase, through prototype construction and verification, to design transfer. In doing so, we combine technical know-how with regulatory expertise, thus creating the basis for a smooth and secure market entry.
Our services are aimed at start-ups, medium-sized companies, and international manufacturers alike. We specialize in complex technical systems with high design and documentation requirements. Our team is conversant with the industry-specific regulations – from medical devices (MDD/MDR, 21 CFR 820) to laboratory and analytical technology, and photonics applications. This is how we ensure that product files are created in accordance with standards, are complete, and are traceable.
Our Regulatory Affairs Video
At JÜKE, we support and partner our customers throughout the entire product life cycle. Our video shows you how we can advise you on the design and approval strategy of a medical device and ensure the conditions for a smooth market entry.
When the video is played, personal data (IP address) is transmitted to the operator of the video platform. Therefore, it is possible that access data may be stored and analyzed. Detailed information can be found in our privacy policy.
When the video is played, personal data (IP address) is transmitted to the operator of the video platform. Therefore, it is possible that access data may be stored and analyzed. Detailed information can be found in our privacy policy.
