Jüke Systemtechnik GmbH
Booth number 4105-43Jüke is service provider for product and system development, contract manufacturing and regulatory affairs for customers from medical, analytical and laboratory technology.
About us
Jüke is an experienced service provider for product development, contract manufacturing and regulatory affairs. We work for companies in the fields of medical technology, analytical, bio and laboratory technology as well as photonics. Our experts have many years of experience with complex mechatronic assemblies and devices, firmware and software programming, system integration and documentation according to current standards and guidelines. Jüke is ISO 13485 certified and is a reliable partner for all phases of the product life cycle.
Address
Jüke Systemtechnik GmbH
Trumpenstiege 2
48341 Altenberge
Germany
Phone: +49 2505 87-0
Fax: +49 2505 87-800
Internet: www.jueke.de
Products & Services
Jüke works exclusively for companies in the fields of medical technology, analysis, biotechnology, laboratory technology and photonics. We offer services for product development, contract manufacturing and regulatory affairs. Our main areas of activities are:Photonics
Opto-electronics
Opto-mechanics
Opto-mechatronics
Spectroscopy
Diagnostics
Analytics
Biotechnology
Bioanalytics
Cell analysis
Product Development
System Development / System Integration:
We turn ideas into technical solutions and reliable products.
- Requirements management according to current standards and guidelines
- Concept development and feasibility studies
- Mechanical construction and electronics design
- Firmware and software programming
- Development of prototypes, assemblies, devices and systems according to the V-model
- Obsolescence management
- Lifecycle management, product maintenance with update and upgrade
Contract Manufacturing
Contract Manufacturing / Production:
Flexible production and contract manufacturing directed to the needs and requirements of our customers:
Manufacturing with state-of-the-art infrastructure with CNC machining centers and laser welding,
Assembly, partly in low-dust and air-conditioned assembly facilities,
Quality control, tests and inspections,
Prototyping, small series and serial production,
Supply-Chain-Management,
Customer-specific logistics.
Regulatory Affairs
Benefit from experience: We accompany the process from a validated prototype to an approved medical device.
- Consulting, concept development and implementation
- Quality and risk management
- Documentation according to CE and FDA standards and guidelines
- CE conformity assessment
- Approval support according to MDD, MDR and CFR 820
- Design transfer and product launch
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