Quality

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 & EN ISO 13485:2016 standard, so you can have confidence in our processes, procedures, and systems.

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.

Medical Device Testing

We also offer extensive medical device testing services at Arrotek. We have equipment to complete a range of different tests in addition to an experienced and highly knowledgeable team.

  • Our testing services include:
  • Testing to ISO standards
  • Usability testing
  • Age and transportation testing
  • Design, process, and sterilisation validation
  • Verification of the clinical language in usage instructions
  • And more

To speak to a member of our team about your requirements, please contact us today on +353 (0)71 91 15111. You can also email us on sales@arrotek.com.

Our Medical Device Design Work

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