New identification standards are putting pressure on manufacturers’ submissions. Make sure your sensitivity is up to regulations.
Medical Device Testing
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.
Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.
To accommodate the high demand and help manufacturers meet the May 26, 2021 deadline, WuXi Medical Device Testing recently expanded its chemistry lab in Minnesota.
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:
Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.
As the world faces challenging times, we remain true to our promise to serve and support our customers. We are here to help. Getting lifesaving devices to market has never been so critical, and we’ve taken measures globally to stay resilient and prepared to carry even...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.