Medical device testing

Testing is essential to medical device development, from the first ever concept all the way through to commercially representative product. As device developers, we believe in a tailored approach to medical device testing. Whether it is based on established methodology or a truly innovative solution, we can find the right test for your product.

Our specialist device testing team of scientists, engineers and technicians can support testing throughout your product development and help you develop new products or deliver self-contained medical device testing programmes.

Engineer in the lab

Bespoke test solutions

Where some medical devices such as inhalers and needle injection systems may have established methodologies, others are not as well supported. Medical devices can present unique challenges when applying industry guidance and standards. Our medical device testing team will work with you to translate these industry expectations into meaningful product requirements and specifications with a suite of test methods and protocols tailored to your device.

Robust test solutions need to evolve with your product. This is why we apply our understanding of formal test methods pragmatically from early development stages and always develop them with validation in mind. We can work with you to build on your own test approaches and transfer our developed methods to you.

Our considered approach ensures your product is developed comprehensively, with carefully rationalised test solutions.

Testing for regulatory compliance

Our team brings a detailed understanding of regulatory requirements, compliance and apply them to your programme. Our support can start well before formal method development and testing. We can help you define meaningful design input requirements, driving a comprehensive programme of work, all the while de-risking your regulatory strategy.

The quality and integrity of test data is paramount. We understand the importance of statistical rationale including sample sizes, analyses and acceptance criteria. We bring these elements together to deliver comprehensive reports to the highest quality and compliance standards. This gives you the complete package needed to support your regulatory submission.

We work to the highest quality and compliance standards to deliver the complete package needed to support your regulatory submission.

In-house testing capabilities

The device testing team works across a wide range of medical device sectors, from drug delivery to diagnostics and MedTech. Our expertise includes:

  • Detailed working knowledge of an extensive range of test equipment
  • Product function and performance testing
  • Root-cause investigations of non-conforming products
  • Development of custom testing solutions, including jigs, fixtures, and more complex instruments
  • Early stage electronic prototype builds and bespoke assemblies for agile proof of principle testing
  • Considered and rationalised statistical analyses

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