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 readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
When outsourcing these key functions, asking the right questions will help minimize the risk.