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 new Clinical Evaluation Report (CER) has significantly increased. With the added pressure to adhere to submission deadline, here at Test Labs we are ready to help 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 and 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 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 the microbicidal process is effective.
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 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 and/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 to be used in medical environments to disinfect medical devices. These products must be correctly classified following the rules of Medical Device Regulations as class IIa, IIb or class III.
Annex 9 of the 93/42 – classification of medical devices as referenced in the MDR – rule 15 covers substances and other equipment intended to be used in medical environments to disinfect medical devices: 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 offer test for all types of 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.
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 and/or technology, and 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/or surface damages at a visual, physical, and chemical level.