As regulatory expectations intensify, medical device testing can require more time and budget to satisfy standards. The testing plan decisions you make early on can affect the entire process, so it is critical to think long-term and prioritize quality to avoid...
Around the world, various regulatory factors are driving the evolution of medical device risk evaluation. The industry is beginning to recognize the limitations of biocompatibility testing. While the data it can provide still have a pivotal role in the assessment...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
