Medical Device Design

Our design engineering team has created all sorts of medical and dental devices. From custom toothbrushes to complex smart diagnostics devices, our medical product experts have the experience you need.

Our medical and dental design experts are experienced with all regulatory issues including FDA requirements of medical device design and production.

Our medical experts can design any medical, dental, or veterinary product or invention. We have designed simple tools to flow control systems to complex stand-up testing equipment.

In cases where the device to be designed can be categorized as an FDA medical device, i.e., specifically offered for a human health or medical health business sector, we undertake all necessary steps in the design process to ensure the correct procedures, techniques and protocols are followed to support the design for appropriate submission with all regulatory or controlling (typically government) agencies.

We meet or exceed concurrent Design History File ISO 13485 requirements, Design and Process FMEA (Failure mode effect analysis), FDA 510k preparedness, including clinically specific ancillary performance and parameter compliance risk analysis and design mitigation plan.