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...
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...
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...
Product adoption for radiation sterilization can cut costs and save time today and in the future.
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...
Changes to ISO 11607 parts one and two have left Medical Device Manufacturers (MDMs) wondering how new requirements will impact their business and efforts to prepare for the EU MDR. These regulatory changes add new requirements for package usability and sterile...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
