The path to regulatory approval of a medical device can be long and complex, and the biological safety evaluation is an important milestone. It is a critical part of the V&V phase, as even the best designed products can lead to unintended complications if the device causes a biological reaction in the patient. Well characterized materials widely used in the industry can produce unexpected reactions if processed in a way that leads to harmful response in the human body, or toxicity by leaching toxic compounds into a patient.
The biological safety evaluation process includes biological risk assessment and testing. The numbers and types of tests which are required for a specific medical device depends on many factors such as the nature and duration of contact with the human body and the regulatory requirements. Developing a Biological Evaluation Plan (BEP) according to ISO 10993-1 is an essential step to determine which biocompatibility tests are needed for the specific device.
Biocompatibility testing is required for medical devices intended to have direct or indirect contact with the human body, in order to assess the potential biological risks associated with the device. Biocompatibility testing is essentially part of the risk assessment process with the aim of reducing the risks while maximizing the benefits to patients and users.
The ISO 10993-1 standard “Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process” provides a framework for the development of a biocompatibility evaluation. It is best to consult an expert who is familiar with the particulars of the standard and various regulatory requirements in order to avoid oversight. This is crucial for small start-up companies with limited resources.
There are many elements involved in determining which biocompatibility tests are necessary and how to perform them. Missing a small detail can result in the need for retesting, costing valuable time and money. With our expert knowledge and experience, Li-Med can provide a reliable plan to navigate the complexities of biocompatibility testing, avoiding costly mistakes and increasing efficiency. We serve as your trusted partner, using our insight to identify strategies for saving time, while never compromising on quality. We know that compromised quality can quickly take your product right back to the starting line. That’s why it’s so important to have a smart game plan from the outset—and why we put it at the forefront of every project.
Li-Med is the Israeli representative of Eurofins BioPharma Product Testing
Li-Med and Eurofins collaborate together to provide services such as biological evaluation, chemical characterization, extractables and leachables, to toxicological risk assessments. Eurofins’ dedicated team of consultants and toxicologists can facilitate the appropriate testing to best support your international regulatory submissions. Li-Med provides support for project management and testing strategy, as well as support and assistance throughout the testing process.
Eurofins is an industry leader in the field of testing providing high quality work performed by over 47,000 highly trained professionals. Over 800 state-of-the-art laboratories located around the world use the newest technologies to enable a fast turnaround time and accurate results. Your customers (the patients) are our top priority and Eurofins makes every effort to mitigate risks to their health and safety. Li-med’s experts and Eurofins’ tech support team are always available to answer any question and help with any issue, keeping the customer’s needs as the main focus.
Li-Med’s experts, together with Eurofins can help you to reduce the amount of overall testing, saving precious time and money, enabling you to be first to market. We offer:
- Tailor-made testing strategy for new or modified device.
- A Biological Evaluation Plan (BEP) for new or modified product, in accordance with ISO 10993-1, FDA guidance and other applicable regulatory requirements worldwide. Detailed testing strategy is established and documented based on an in-depth Biological Risk Assessment (BRA).
- Detailed, thorough Biological Evaluation Report (BER).
- Project management service – we take care of orchestrating all efforts in the most cost-effective and time-sensitive manner.
Contact us to get an offer customized for your product.