Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmental Quality.
Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.
Despite pricing pressures, several sectors within the medical device industry can expect to enjoy growth and attract attention from investors.
The disgraced former CEO once oozed total confidence about her company and product, and in latest released footage says “I don’t know” more than 600 times during a 2017 deposition.
“We don’t know how long the shutdown is going to continue,” says the association’s President and CEO Scott Whitaker.
A gap assessment provides a toolbox for the decision-making process.
Lack of preparation and understanding of the efforts required to comply with the regulation will hinder product launches, negatively impact sales, and hurt a company’s reputation.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
Look for the good, the bad, and the ugly, but above all, look for anything that affects patient safety.