Elina Tenhunen

A biological evaluation plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & structure, its material composition, manufacturing process & potential contaminants, the intended use, existing test results, and clinical history. The BEP ensures that the device undergoes sufficient biocompatibility testing, with parameters selected from the ISO 10993-1 standard. As a manufacturer, you will need to have a BEP during the regulatory approval process to demonstrate the safety of your medical device. The BEP should be developed during the initial design phase of the medical device. At this stage, manufacturers can identify potential biological risks associated with the device's intended use, materials, and components. A new BEP or updates to the existing one may also be needed if changes are made to the device's design or material composition at a later point. At Measurlabs, we can provide a BEP for a range of medical devices while also guiding manufacturers throughout the process. Do not hesitate to contact us if you are developing a new device, seeking regulatory approval, making changes to an existing product, conducting post-market surveillance, or performing preclinical testing.  We are also happy to create an offer for biocompatibility testing according to the BEP, as well as a biological evaluation report (BER) to summarize the results of the biological evaluation.

The term bioburden describes the presence of microorganisms on a product, raw material, or surface. Bioburden testing plays a crucial role in the quality control of medical devices, pharmaceutical products, and their components. This analysis follows the ISO 11737-1 standard to detect populations of viable microorganisms on a product before sterilization, indicating the microbiological cleanliness of the product. ISO 11737-1 is recognized in the EU as a harmonized medical device standard and by the FDA as a consensus standard. This makes it the recommended way to evaluate bioburden under the EU MDR and the FDA 510(k) premarket submission process. This example testing package includes the following: Testing of 5 identical specimens, Detecting the presence of aerobic bacteria and fungi (yeasts and molds), Validating the bioburden determination technique, Results expressed as total CFU/test product (CFU=colony forming units), Tests under GLP. We can also offer custom bioburden test packages, especially for customers with large annual sample volumes. Please ask our experts for a quotation and estimated turnaround time.

Chemical characterization according to the ISO 10993-18 standard is performed to identify the constituents of a medical device and to estimate and control the risks associated with its chemical composition. The test is a key part of assessing the biocompatibility of medical devices. Chemical characterization includes the estimation of substances released under simulated or exaggerated laboratory conditions (extractables) or the detection of actually released substances (leachables) by the medical device during clinical use. Applicable methods may include HS-GC (volatile organic compounds), GC-MS (semi-volatile organic compounds), LC-MS (non-volatile organic compounds), and ICP-MS (inorganic elements). Suitable tests, solvents, and analysis methods are chosen according to the device's composition, intended contact time, and site. Any chemicals detected above concentrations established to be safe require further evaluation, typically through a toxicological risk assessment (ISO 10993-17). We provide a range of chemical characterization tests customized to the product, the intended market area (MDR, FDA), and quality requirements (GLP, accreditation). The starting price is based on the chemical characterization of volatile organic compounds (GLP, FDA).

ISO 10993-17 provides a structured approach to establishing safe exposure levels for chemicals released by medical devices during clinical use. A toxicological risk assessment in accordance with the standard is typically required if extractable and leachable substances are discovered during chemical characterization (ISO 10993-18) in concentrations above the analytical evaluation threshold (AET). A comprehensive risk assessment is created using toxicological data from existing literature, or mathematical tools when data on particular substances are unavailable.  The assessment will include: A summary of the toxicological profile of substances flagged from the device's chemical characterization and determination of their respective permissible exposure limits., A calculation of the margin of safety between actual patient exposure and permissible exposure limits, considering various toxicological endpoints., A final assessment of whether a leachable poses a significant toxicological risk, including recommendations on ensuring compliance with safety thresholds.. The displayed starting price includes the evaluation of one extractable chemical and the reporting fee. Typically, multiple substances are evaluated during the risk assessment, but the price per substance is significantly lower for additional chemicals. The extent of the required toxicological evaluation depends on the results of the ISO 10993-18 chemical characterization, which we can also offer if not yet completed. Contact our experts using the form below to get a tailored quote.