The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.
It’s time to address this healthcare problem.
Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.
A gap assessment provides a toolbox for the decision-making process.
Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.
With the evolution of medical electric technology, EMC concerns are crucial.
When outsourcing these key functions, asking the right questions will help minimize the risk.
Look for the good, the bad, and the ugly, but above all, look for anything that affects patient safety.
As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is especially troubling given the financial challenges many hospitals face.