Services available for Patient-worn monitors

We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.

We validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.

We develop cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.

We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.

Whether you’re refining a prototype, investigating a failure mode, or pushing the limits of what your device can do, we’re here to provide the technical testing support you need.

We perform accelerated aging testing and real time
ageing studies to determine how a products behave
under normal storage/use conditions over long periods
of time.

We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series

We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.

We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.

We offer ISO 10993-23 tests to determine irritation potential of their devices without the need for animal testing.

We produce a report which is a collective summary of all data used to assess the biocompatibility of your medical device.

We complete Biological Safety Evaluation, following ISO 10993-1 standard to address possible biological hazards and risks associated with the clinical use of your medical device.