Biological evaluation of medical devices is a complex process that represents a part of the overall development of a medical device. It consists in the review and evaluation of existing data and the selection of additional tests to guarantee the safety of the product.
Galileo Research can drive the nonclinical development of your medical device, planning the biological evaluation within the framework of ISO 10993 standards and delivering all the pertaining documents for regulatory purposes.
Galileo Research provides the medical device industry with customised biocompatibility service according to ISO 10993 standard requirements and in compliance with GLP.
The following tests can be conducted in our laboratories according to ISO 10993-1, OECD and GLP standards.