At Bartek Design we back up our Medical Device Product Designs with the Design Control documents required to support the regulatory requirements for New Products release. All Design Controls conform to European CE Marking and USA FDA directives. Bartek work closely with your Quality Assurance Teams to develop the Design Control Inputs, User Needs, requirements and specifications to populate your DHF to have it ready for the CE Marking or 510K submissions to achieve as successfully market product release. Contact us for details.
1. User Needs
4. Design Output