Bartek Design

Product Design

Bartek Design specialise in designing and developing Healthcare and Medical Devices for the consumer market. We have 30 years experience in bringing new products from design to manufacturing using concurrent engineering practises.

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.

Prototyping

Bartek has extensive experience in Prototyping new products during their development phase, be it for looks and feel, for functional testing or even clinical trials. We utilise the latest prototyping and manufacturing techniques to ensure the best possible outcome for each model.

Services

Bartek have extensive experience in developing products from concept to production. We have knowledge of the complete manufacturing process from tooling to manufacturing and Quality. We offer our experience on a consulting basis to suit your requirements. Contact us for details.


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