Here are the most read articles of the year.
Trends that push boundaries and shake up medical device security.
Reduce risk and control your label, its design, and the data.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
A gap assessment provides a toolbox for the decision-making process.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
Amazon Comprehend Medical uses machine learning to pull important medical information from patient records.
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.
Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.