Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
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.
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.