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.
Following protocols and maintaining compliance have been common themes.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
A look at where tech developments are originating and what to expect.
Many considerations should not be overlooked.