All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”. The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.
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.