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An Overview of the Medical Device Design and Product Development Process

by Mark Pugh
While each new medical device product design and development project is different, the process followed is typically well-structured. There are many reasons for this, not least the importance of ensuring the product is safe to use as well as ensuring both the product itself and the design process adheres to medical device regulations. At Arrotek, we have a well-established medical device design and product development process. It is outlined below. Before going through it, however, it may also be helpful to read our blog on the Considerations that Inform and Guide the Medical Device Product Design Process. Both blogs together...

Considerations that Inform and Guide the Medical Device Product Design Process

by Mark Pugh
Turning an idea for a new medical device into a product that is ready for testing and evaluation is a complex process, particularly if you have never been through it before. This overview of the medical device design and development process will outline the things you and your design/development team will consider. In the next blog, we’ll look at the steps and stages you will go through. Considerations During the Design and Development Process for New Medical Devices There are many concepts, principles, and requirements that will determine the course of the design process. This includes: Regulations DFM – Design...