April 13, 2023
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...
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April 7, 2022
This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...
See BlogMay 26, 2021
It is D-day, or the Day of Application (DoA) for the Medical Device Regulation (MDR) EU 2017/745. Years of hard work have preceded this date to prepare for this new regulation. The key message of the MDR is to minimize...
See BlogMay 7, 2021
Every medical device on the market must be evaluated for its potential to cause irritation, from a knee brace to an artificial cardiac pacemaker, regardless of whether it has a short-term or long-term exposure to the user/patient. This is a...
See BlogFebruary 18, 2021
The requirements for assessing irritation for medical devices has moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing as a recognized method. This is a critical turning point as...
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Join us for a free one-day pharma seminar and open house at our Nelson Labs Itasca, IL Facility on June 22, 2023. |
