In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.
No one genuinely enjoys doing paperwork. At best, people may dislike paperwork less than other parts of their jobs. Yet the FDA requires a certain amount of paperwork to document processes and results for the medical devices under their jurisdiction
In one’s personal life, many people just shrug their shoulders, and go about their day; however if a multi-million dollar investment, or someone’s life, is on the line, engineers need to take steps to prevent it from happening again.
EMMA International has entered into a strategic partnership with Thema, an Italian based strategic-regulatory consulting company. The goal of this strategic partnership is to expand geographical offerings to companies operating in the life sciences regulated space.
October is the month that is designated internationally to bring awareness to the impact of breast cancer. The best screening tool to find cancer remains the mammogram. A mammogram is a low-dose x-ray picture of the breast. As in any cancer, early detection is key.