Medical Device Material Compatibility Assessment

We analyse test item materials at both sample and product level to assess process compatibility.

Disinfectants and cleaning agents applied to surfaces and products, in formats such as liquids, sprays, and vapours, have the potential to cause chemical damage as well as changes in the visual appearance and physical properties of the materials they come into contact with.

Through our Material Compatibility Testing service, we developed a custom testing plan that takes into consideration the mode of action and recommended use of your disinfectant product and/or technology. We measure the effects of your products on a wide variety of materials, helping you to determine the damages that can happen overtime.

Using our team’s expertise in material science, we developed a series of in-house tests based on industry standards to properly analyse test item materials at both sample and product level during the Initial and Final Assessments.

Results from these tests provide important qualitative and quantitative data for assessing potential structural and surface damage at a visual, physical, and chemical level.

FDA Medical Device Material Performance Requirements – Guide

Medical Device Material Compatibility – What is the impact of failure?

Post-Market Surveillance (PMS): Everything You Need to Know

The purpose of a PMS system is to identify risks, not previously known, and opportunities for improvement in a timely fashion

Explore our medical device testing services

Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

Medical devices bioburden testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

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Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials

Strong foundations are built with robust Quality Management Systems