The medical device reports describe both patient infections and other possible contamination issues.
Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.
The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.
The company was accused of hiding serious health risks related to implantation of its transvaginal surgical mesh products.
Bayer’s second quarterly analysis report of adverse event information includes nearly 12,000 serious injuries, 45 malfunction reports and nine deaths.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience.
There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue.