Sterilization validation is necessary to bring tissue-based products to market. The U.S. FDA requires it, whether the device functions in vivo or in vitro, so understanding how to ensure sterility is critical. When it comes to living tissue, the process carries an...
The Critical Role Reprocessing Instructions Play in a Medical Device’s IFUs
Drafting Instructions for Use (IFUs) for medical devices is a delicate but critical task that supports patient safety. IFUs need to include detailed, action-oriented instructions on preparing, administering, handling, storing and disposing of the device. When...
Are You Prepared If Your Disinfectant Is Discontinued?
The U.S. EPA banned the active ingredient in a popular disinfectant in 2018. Would you know what to do if your go-to cleaning product was phased out?
How Should Medtech Manufacturers Cope With Sterilization Plant Closures?
The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers.
Radiation Sterilization: Verifying Dose Survivors
A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers. In last week’s blog post, we highlighted the...
Our All-Inclusive Approach to Microbial Identification
WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories. Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.