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...
As stated in the international packaging standard, ISO 11607, designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. Even if manufacturers opt for a proven packaging configuration, it needs to...
ISO 11607 and MDR—package testing and validation impacts Medical device manufacturers around the world are working to ensure their package designs are in line with the recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR). Britt...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
