Product Solutions in the regulated environment

  • As specialists in component development for medical devices, we are certified in accordance with ISO DIN EN 13485. EXCO-developed products and electronic components for medical devices meet the highest requirements when it comes to quality assurance and usability.

  • We ensure that the hardware and software in products that are used in the regulated industries conform to the specific properties. Using verification procedures, we provide documented evidence that the test specimen possesses the specified properties – regardless of use, purpose and benefits.

  • EXCO will examine your processes and documentation to ensure compliance with the requirements of the new European MDR/IVDR. Subsequently, EXCO will provide specific advice and recommendations for action and implement entire work packages.

  • EXCO is a specialist in developing complex products with embedded systems in the regulated environment and medical technology.