ClearStream's expertise in design and CE marking, coupled with our experience in manufacturing of finished devices, makes us an excellent solution to your product development problems.
Our benefits include:
- Our contract philosophy is to enable flexible exit from and entry to the design/manufacturing chain at any stage.
- This flexible approach gives you choice and control over the product development process.
- All design work is conducted under full EN46001 design control and is supported by a full regulatory service.
- Our fully integrated service enabling concurrent engineering ensures rapid time to market.
- We also offer customisation of ClearStream products to meet your specific needs.
Product Development Services
From concept through feasibility study, prototype stage to the final design, our product development team will work with you to bring your product to market.
Our team of engineers have extensive experience in the design and development of finished medical devices, including PTA/PTCA catheters and other stent delivery systems.
Working to ISO13485 and working with our regulatory group, our product development team will ensure that all documentation and validations facilitate CE marking of the final product.
Time to market is critical for any new medical device. The ClearStream Technologies solution is to offer a fully integrated service from concept to market with unique capabilities. We can design, validate, manufacture your products and ship them to the markets of your choice.
Contract Manufacturing Services
Medical Device Assembly
- Precision assembly
- Angioplasty balloon blowing
- Plastic bonding and fusing
Medical Equipment Assembly
- Electro-mechanical assembly and test
- JIT assembly workcell structure
- Service and repair of electromechanical equipment
Supporting our customers
- Highly skilled and trained workforce
- Experienced engineering support
- EN46001 quality system including design control
- Extensive product transfer and process qualification competencies
- Product development capability
- CE marking experience
- 2600 square metre facility
- Temperature, humidity and particle controlled manufacturing environment
- Computer purchasing, stock, work order and customer order control systems
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