Design Controls
Bartek has the unique position of having extensive knowledge of the current CE and FDA Design Control Regulatory Requirements required to release new products to market, and we combine this knowledge with our Product Design to populate the DHF in order to ensure that our customers products achieve successful regulatory approvals for market release.
Simulation
A Medical Device cannot be released for CE Marking or FDA Approvals without .first demonstrating extensive testing and test data. At Bartek we support this requirement by using Computer FEA Simulations giving extensive data to prove the structural strength and functionality of the Device before it is even prototyped for Human Factor Ergonomics and real life functional Mechanical testing.
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