The device approvals address critical patient need.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
The agency issued a letter to healthcare providers following a journal study about the potential risk of these devices in patients with a type of peripheral arterial disease.
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
Here are the most read articles of the year.
It’s the body’s first line of defense, and this important organ should not be an afterthought.
While the road to bringing a medical device to market is often bumpy, working with an experienced and knowledgeable partner can help navigate the process and potentially avoid some of the bumps.
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.