The Device Design team offers the following services:
Feasibility studies
Benchmarking of products and materials in different models
3D-CAD Design for devices and packaging
Rapid prototyping
Pilot production
Process validation
Design verification
Scalable designs and optimization for volume production
Handling of all regulatory requirements such as accelerated aging tests, biocompatibility tests, packaging and transportation simulation, sterilization validation, etc.
Creation of documentation according to CE and FDA standards
CE approval and regulatory support for other local approvals
Customer access to Design and Development facilities and labs
Device Design Technology and Resources
Test laboratory for benchmarking and material testing
Prototyping laboratory
Various balloon forming technologies
Various bonding technologies (laser, hot air, heated clamps, gluing, etc.)
Various benchmarking models
Crimping of balloon expandable stents
Drug coating of balloons
Safety work bench for the treatment of cytotoxic drugs
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