Quality assurance is sometimes an activity that is added at the end of the project. In our design controls, reviews and quality control points are performed throughout the project. Our document templates make the documentation work easier and familiar for our engineers which in the end reduce cost and improve quality
On a regular basis, customers come to us with products that are closed to finished but lack the proper documentation. We help them by assessing their documentation needs both from an internal customer standpoint and from a regulatory viewpoint for medical devices. All products sold in Europe require a CE mark. A company that has an EC certificate can put the CE mark on medical device products itself. One of the cornerstones for an EC certificate is to have a quality system implemented in the company. We can support customers with a template quality system that we have used for several customers to help them receive an EC certificate.