New identification standards are putting pressure on manufacturers’ submissions. Make sure your sensitivity is up to regulations.
A risk-based approach that tailors test requirements to the specific risks of each device.
Product adoption for radiation sterilization can cut costs and save time today and in the future.
The FDA’s Good Laboratory Practice (GLP) regulations have led to some misconceptions for medical device manufacturers (MDMs). To better understand the misconceptions about when to apply GLP testing, I think it’s important to first look at what the FDA GLPs actually say:
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...
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.