Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
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.
This mode of personalized medicine helps doctors make more informed decisions related to drug therapies.
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.
It is time to extend AI’s use into labor & delivery departments, where the technology can help guide care teams to mitigate risks and make informed decisions.
Smart technologies will continue to play a big role in advancing decision-making efforts.
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.