Understanding Medical Device Verification and Validation When it comes to ensuring the safety and efficacy of medical devices, rigorous processes are in place to verify and validate their performance. This blog will delve into the world of Class II medical devices,...
Medical Device Industry Trends for 2024 and Beyond The medical device industry is constantly evolving, driven by advancements in technology, changing healthcare needs, and a growing focus on patient-centric care. As we look ahead to 2024 and beyond, several key trends...
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...
Quality Medical Devices Start with a Quality Manufacturer Medical device component manufacturers are the backbone of your Class II medical device operation. Whether it’s a life-saving implant, a diagnostic instrument, or a sophisticated monitoring device, the quality...
Innovation plays a pivotal role in enhancing patient care, diagnostics, and treatment outcomes. One critical aspect of this innovation is the design and development of Class II medical devices. This process involves a variety of stages, ensuring the final product...
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?
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
