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.

  • Quality management according to ISO 13485

  • Creation of documents (DHF, DMR) according to CE and FDA requirements

  • CE-conformity declaration

  • Supervision of the CB type testing

  • Know-how about current approval topics

  • Establishment of risk management files in accordance with ISO 14971

  • Comprehensive knowledge of standards and guidelines for medical technology

  • Product adaption to changed regulatory requirements

  • Know-how about current approval topics

Challenge us!

Benefit from the experience of our experts.
Please contact us here.

We are open for all requests.