Medical Device Testing

We provide a focused range of MedTech testing solutions that excel your product approval process during your journey to market.

Clinical Evaluation

Our team of professionals will develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.

With the current transition period from MDD to the MDR, the need to maintain existing or create a new Clinical Evaluation Report (CER) has significantly increased. With the added pressure to adhere to the submission deadline, here at Test Labs we are ready to help you create a comprehensive and exhaustive CER.

Our team of professionals will develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to a medical device.

This will allow us to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.

The clinical evaluation will be based on a comprehensive analysis of available pre- and post-market clinical data relevant to the intended purpose of the medical device, including clinical performance data and clinical safety data.

Following predefined methods and the guideline of MEDDEV 2.7.1 Rev 4, your CER journey can be made easy at Test Labs.

As part of MDR requirement, re-processable medical device manufacturers must provide instructions describing cleaning, disinfection and sterilization and prove that these procedures are valid.

Medical device manufacturers must also demonstrate the safety of the product after reprocessing and over the entire product life cycle.

Medical device cleaning, disinfection and sterilization validations are a critical component to the overall reprocessing validation. It proves that the device can be cleaned, disinfected and sterilized following the manufacturer’s instructions for use (IFU).

Organic matter left on the device can inhibit the disinfection or sterilization process by protecting microbes from the disinfection or sterilization agents, therefore it is essential that the cleaning process is effective.

Likewise, the manufacturer’s instructions for the disinfection or sterilization steps must be validated to show that the microbicidal process is effective.

Reusable medical device reprocessing validation

Our team will evaluate your procedures for manual and automatic cleaning, disinfection and sterilisation.

Medical device bioburden testing

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

To ensure a level of cleanliness, manufacturers need to determine the presence or absence of bioburden on their sterile or non-sterile medical devices according to requirements of ISO 11737-1:2018.

The medical device Bioburden test determines the total number of viable microorganisms in or on a medical device, container, or component. It is performed on any product that requires control or monitoring of bioburden counts.

Even if the risk of product contamination is maintained at low level, the bioburden of the product may fluctuate from batch to batch. Therefore, product manufacturers are recommended to conduct routine tests regularly.

Failure to accurately assess bioburden could result in inadequate processing controls and data supporting the sterile claim of products.

For medical devices, bioburden test data helps establish the parameters for an effective sterilization process.

In order to ensure the ongoing safety of the sterilization process, it is necessary to verify that the bioburden level remains consistent over time.

We offer a wide range of tests for determining the efficacy of disinfectant products for medical devices. These products must be correctly classified following the rules of Medical Device Regulations as class IIa, IIb or class III.

The applicable annex in the MDR which covers the classification of medical devices states below:

All devices intended specifically used for disinfecting medical devices must be classified as Class IIa.

All devices specifically intended to disinfect invasive medical devices must be classified as Class IIb device.

We also offer disinfectant efficacy tests for products such as wipes, sprays, hand sanitisers, automated units. In addition to offering UKAS accredited reports, we will guide you during your product journey to the market.

Disinfection products for medical devices

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

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 of causing chemical damage as well as changes in the visual appearance and physical properties of the materials they come in contact with.

Through our Material Compatibility Testing service, we develop a custom testing plan that takes into consideration the mode of action and recommended use of your disinfectant product or technology.

As a result, 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 expertise on 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 product and surface damages at a visual, physical, and chemical level.

Test labs offer tests which aid in addressing the biocompatibility of medical device materials. These tests enable the evaluation of a proposed medical device in terms of cytotoxic potential and chemical analysis to identify biological risks.

Our Cytotoxicity testing (ISO 10993-5) is a crucial test for determining the effects of any medical device that encounters human tissue. This in-vitro test involves the extraction of potential toxins from the medical device through cell culturing techniques, which is validated by the ISO 10993-12 standard. The device extracts are then exposed to mammalian cells of mice origin (L929 or BALB/3T3 cells), under a range of concentrations. Cytotoxic effects are then observed through a variety of qualitative (Colony formation) and quantitative (NRU, MTT and XTT) tests.

Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

IEC 60601-1 Pre-Compliance Evaluation

We test your device, mitigating the cost of repeated compliance testing by evaluating potential non-compliances.

In order to comply with MDR requirements, medical electrical device (ME device) manufacturers must send their products to a certification test house and meet the many requirements laid out in IEC 60601-1. This is a costly and challenging process – it is exceedingly rare for a device to pass the requirements first time – often taking years of work and tens of thousands of pounds in costs.

At Test Labs, we offer an IEC 60601-1 pre-compliance evaluation service to help manufacturers avoid expensive repeat testing with a certification test house. Before you submit your device for compliance testing, Test Labs will perform a review of the associated documentation of a device (such as the risk file, markings, instructions for use (IFU), etc.), test the device for compatibility with the IFU using repeated cleaning, disinfection, and sterilization cycles, and perform basic electrical, mechanical and temperature safety tests.

Our approach is your success story

We support you in bringing your products to the market because your performance is the measure of our relevance