March 21, 2022
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....
See BlogFebruary 22, 2022
Ensuring that reusable devices can be properly cleaned, disinfected and/or sterilized is imperative to ensure patient safety and to minimize healthcare-acquired infections, corrective actions, and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about the spread of diseases, including...
See BlogDecember 7, 2021
Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key concepts about sterilization. The purpose of sterilization is to inactivate microbiological contaminants, thereby rendering products sterile[1]. The kinetics of inactivation...
See BlogMay 4, 2018
We are excited to share the news that our Nelson Labs facility in Itasca, IL significantly expanded lab operations and testing capabilities to better serve our customer needs. Lab customers will benefit from state-of-the-art facility and equipment upgrades to the...
See BlogFebruary 22, 2017
At Nelson Laboratories, our values hinge on quality, service, and expertise. Our quality systems and world-class facilities are part of what elevates us in the MedTech industry. We recently completed a two-year renovation to our state-of-the-art ISO Class 5 cleanroom....
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Regulatory Compliance Associates is now part of Nelson Labs! RCA's quality, regulatory, and technical experts know how to navigate complex challenges and help life science companies safely maximize their market potential. |
