Quality & regulatory
Product development often involves a lot of regulations. In particular with medical products, a series of standards must be met. We can support you to get a good overview of the regulations and to ensure that your product complies with all the rules and requirements.
Support in QARA
We make sure your product meets the regulatory requirements. We have expertise regarding regulation (EU) 2017/745 (= MDR). Including medical device classification & assessment routes, risk management, applicable regulations, directives and standards.
We offer guidance for QMS systems and ISO 13485. Comate has implemented a quality management system with processes according to the requirements of ISO 13485. This enables us to perform design, development and risk management activities in a controlled manner in order to deliver products that meet the strict requirements of the medical device market.
We are proud to have acquired the ISO 13485 certification for medical design services. This achievement proves that we invest in understanding our clients needs and working with them to deliver high quality solutions, whilst continuously reviewing and improving the way we work.
Setup of technical documentation
A medical device is subject to many regulations. A technical documentation set is mandatory. During the development of your product, we offer assistance in building the necessary technical documentation to get your device to the market.