All medical devices have to undergo a biological evaluation of biocompatibility to fulfill the requirements in the EU Medical Device Regulation (MDR). We can help you with everything from setting up a biological safety evaluation plan according to ISO 10993 and ISO 14971 to performing the required tests.
The aim of the biological safety evaluation is to ensure that possible negative effects on human health caused by the materials in the product shall be identified and managed. We are a dedicated collaboration partner with solid knowledge about current regulations, available test methods and good test strategies. We are also the only laboratory in Sweden to offer cell based test methods according to the quality system Good Laboratory Practice (GLP) to external customers.
In the EU and in the US, the legislative requirements for biocompatibility of materials in medical devices are similar. The standard series ISO 10993, describing test strategies and – methods to ensure biocompatibility, is combined with the standard ISO 14971, which concerns risk management for medical devices. These two standards form the framework for generating a biological safety evaluation plan.
Generating a biological safety evaluation plan is performed in several steps:
RISE has extensive personnel and instrumental resources available, to perform all steps up to a complete biological safety evaluation plan.
Results from testing or evaluation are presented in one or several reports in Swedish or in English as agreed with the customer. For tests performed according to GLP, a study plan is set up before the start of the test.
Please contact one of the persons at the bottom of this page.
Biological evaluation of medical devices according to ISO 10993
Medical devices, Product safety
ISO 10993-series, ISO 14971, ISO/IEC 17025, OECD principles of Good Laboratory Practice
Price on tender
Stated in the tender and depends on the type of assignment.
In case testing shall be performed, information about the test item(s) is given in a sample submission form submitted to us at RISE together with the test item(s). It is the responsibility of the customer to characterise the test item(s) sufficiently to fulfill GLP requirements.