Medical Device Quality and Testing
Medical device regulators place a significant emphasis on quality, so it is essential quality is part of the design and development process. At Arrotek, we have the expertise and experience required to meet the requirements of regulators in terms of quality as well as to ensure the quality standards achieved improve patient outcomes, reduce risk, and increase the commercial viability of your new medical device.
Our internal Quality Management System is accredited to ISO 13485:2016 and EN ISO 13485:2016 standard, so you can have confidence in our processes, procedures, and systems.
Download our Quality Certificate.
Furthermore, we will look after the process of creating a Quality Management System for your medical device.
Please contact us using the form on this page to find out more about how we can help you bring your idea for a new medical device to the market.