Products

Design and development

Design and development usually start with a great idea for a product, a product line, or a service. Starting with the initial ideas, a design team seeks ways to create a tangible that can be sold, installed and used effectively and economically. But the design of a medical device is tightly controlled by the FDA’s Design Control regulations! Mr. Besseling is an expert in Design Control and the integration of Risk Management with Design Control, and did teach that subject at the University of Southern California (USC). The design process must be planned, and a Customer Requirement Specification must be composed, followed by a Design Requirement Specification. For larger systems, these specifications are divided into sub-system documents. Prototypes must be built, tested, and the user requirements must be validated. The design process steps must be reviewed regularly.

One needs careful management to make sure all pieces of the puzzle fit perfectly at the end of the development. On the download page of this website you will find a flowchart that visualizes the design program of a medical device.

BesTech can run the development program for you, or help you in areas where you lack expertise or personnel, ensuring compliance with all FDA and CE regulations.

FDA consulting  ·  CE-marking  ·  Medical device consulting  ·  Product development  ·  Medical device safety testing