Design and Development Services

Design and Development Services

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 
  • Clean room for high volume serial production
  • In-House tool shop