Medical device testing is the process of demonstrating the safety and performance in the laboratory, ready for clinical use. It forms a crucial part of the Design Validation for active and non-active devices, combination products, and drug delivery devices. Careful protocol development and implementation can ensure an effective and efficient delivery of the test programme. An ISO/IEC Accredited 17025 Quality Management System, combined with good training and logic, ensures accurate results and reporting.
Medical Engineering Technologies has been supporting medical device manufacturers and developers since 1997, giving us experience of a wide variety of devices. During this time, many of our reports have been reviewed by Notified Bodies and the FDA. This laboratory work is delivered by scientists and engineers who understand the uses and the regulatory requirements in ‘real world’ applications. Our 'global excellence in medical device testing programme' uses risk analysis and a thorough understanding of international standards to develop and implement robust programmes in the most efficient manner possible. Wherever you are in the world, our service will feel like we are neighbours. Our service team will feel like a friendly and knowledgeable extension of your project team intent on the best performance possible. Here, we think like medical device engineers.