Koven cardiovascular innovation

Your Biomedical Design & Development Partner

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Koven will support your drive for market success by building and executing a comprehensive design transfer plan that takes development costs, finished product costs, and final concept feasibility into consideration.

Our proactive approach, detailed planning, and consistent execution will help you keep on budget and on schedule to meet your market launch needs.

Koven will prepare a comprehensive design transfer plan that complies with 21 CFR 820 and prepares you to:

  • Meet production milestones
  • Meet COGS targets
  • Produce quality lots
  • Deliver a reliable product and process

We can help with:

  • pFMEA
  • Supplier sourcing and vetting according to ISO 13485
  • Fixturing and tooling development
  • Validation of manufacturing & test instructions
  • Design and process optimization
  • 1st article inspections
  • Pilot builds

Every stage of product development can benefit from a review of design suitability for transition to manufacturing. Let us show you how!

Design Transfer Services