Medical devices need to reach patients in the most pristine condition to ensure safety and reduce the risk of unintended infection. Testing the integrity of medical device packaging is a crucial step in ensuring devices are transported and stored without being...
When medical device manufacturers need to interact with U.S. regulatory agencies about the products they’re developing, they use the Q-Submission (Q-Sub) program. The program allows manufacturers to engage in collaborative discussions with regulators that can shape...
Cytotoxicity testing is one of the standard biocompatibility tests for nearly all medical devices irrespective of their duration and nature of patient contact per ISO 10993-1:2018 and the U.S. FDA's Guidance on the Use of ISO 10993-1 (2020). Although cytotoxicity...
As the world of medical technology progresses, so does the landscape of regulatory expectations. Gone are the days when unknown chemicals would be allowed or accepted in preclinical testing. For today's regulatory bodies, ambiguity in chemical characterization is no...
Medical device packaging validation helps ensure that a medical device cleared for commercialization will arrive to the end-user in an uncompromised, sterile state, and non-sterile product remains uncompromised during its journey to the user. Here are five important...
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...
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...
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?
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.
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
