Biological evaluation, including biocompatibility, is a critical early step in the regulatory approval pathway of a medical device defined by the ISO 10993 standard series, which governs biological evaluation of medical devices. Even the most novel and well-designed products can produce complications if their materials cause a reaction in the patient. Even products made using materials that are widely used in the medical device industry can lead to unexpected reactions as a result of their processing.
Eurofins is an ISO/IEC 17025 accredited testing laboratory providing end-to-end services with seamless solutions for all stages of the product lifecycle from design and development through product manufacture, regulatory approval and marketing. Their state-of-the-art analytical techniques enable medical device companies ensure their products meet the highest standards and the most stringent quality and safety requirements.
Through this partnership Li-Med is able to offer a full range of Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP)- and ISO 10993-compliant biocompatibility testing as well as other biological evaluation tests suitable for Israeli companies that are developing medical devices, Pharmaceuticals and Medical cannabis products.
Combining Eurofin’s expertise in medical device testing with Li-Med’s expertise in regulation and quality assurance, we can develop an appropriate testing program that is tailored to the specific regulatory requirements and risk profile of each product.