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.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.
The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
Getting your requirements right early in the development process can help avoid problems during final manufacturing.