Regulatory Affairs.
Benefit from our experience.
We offer our services for the process from the first concept draft through the entire development, prototyping and verification. We accompany the validation and carry out the design transfer up to an approved medical device. An all-round carefree package.
Our services include consulting for both small companies new in the medical device market and global players with a long product history. We focus on class IIa, IIb and III devices with strict design and document control requirements. We are specialized in complex technical devices where we take over responsibility for development up to serial production for the projects of our customers. Our experts have application-specific knowledge in various areas of medical technology and in-vitro diagnostics, so we are familiar with the structure of technical documentation and design dossiers in these areas.
From design to product launch
Development, consulting, implementation for series production and market launch of new products according to MDD/MDR and 21 CFR 820.
Quality and risk management
We ensure that medical devices comply with current legal requirements and that a safe risk management is established.
Market observation and post market surveillance
Consulting and development of a proactive and systematic process for a monitoring of medical devices after they have been placed on the market.
Our video on Regulatory Affairs
At Jüke, we support and accompany our customers as partners throughout the entire product life cycle. Our video shows you how we can advise you on the design and regulatory strategy of a medical device and create the conditions for a smooth market entry.
Our service is based on experience and competence.
Challenge us!
Benefit from the experience of our experts.
Please contact us here.
We are open for all requests.
