One of the goals we have for our medical device engineering projects is to ensure a high-quality medical device that is delivered at an exciting speed-to-market. At Genesis, we have an ISO 13485 2003 Certified Quality System through which we develop medical devices.
In the beginning, we do engagement with the end user to define what are the user requirements for the product. Those requirements are converted into what we call Design Inputs. The Design Inputs then are converted into specifications, which we refer to as Design Outputs.
The product testing is completed according to protocols that we create, develop, and follow up on. While most of the testing is completed by one of our strategic vendor partners, we do a small amount internally as well.