The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Nelson Labs has recently received ASCA accreditation for Biocompatibility, specifically cytotoxicity and sample preparation (ID TL-65). The Accreditation Scheme for Conformity Assessment (ASCA) is offered through the FDA CDRH Standards and Conformity Assessment Program (S-CAP). The goals of the ASCA...
Six steps to assess the situation and determine how to move forward… Each medical device present or coming on the market needs to have a demonstrated biocompatibility to protect users from potential biological risks arising from its intended clinical use....
Cytotoxicity endpoint is marked for all medical devices that contact the patient/user, regardless of type or duration of contact. A cytotoxicity test is an in vitro cell culture assay where the medical-device extract is placed in contact with mammalian fibroblast...
To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018). However, some of these...
