Medical device manufacturers’ one-stop library for critical design, manufacturing, assembly, sterilization, validation and program management guidance from industry experts.
Turnkey Sterile Medical Device Packaging and Sterilization Solutions Our turnkey packaging services are ideal for sterile surgical and procedure kits where multiple components are packed together and lot control and traceability are of the highest importance. Our packaging processes are validated and we have a long track record of exceptional on-time delivery. We specialize in medical device contract manufacturing of both small and…
There is a lot of excitement in the medical device packaging industry about pre-validated packaging. Using pre-validated packaging may reduce time to market and minimize expense related to package development and validation.
Determining a medical device’s shelf life can be one of the more challenging aspects of a new device development program. Manufacturers must account for internal (component interactions and material degradation) and external (manufacturing, sterilization, shipping and storage) variables that will influence shelf life claims. These claims are developed via rigorous testing. An ideal shelf life testing strategy is proposed.
According to the World Health Organization (WHO), healthcare-associated infections (HAIs) are the most frequent adverse event in the delivery of healthcare services worldwide. Ensuring the sterility of medical devices is a critical step in the overall effort to reduce the rate of infections in hospitals and other healthcare settings.