Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

Will New User Fees Fuel More FDA Inspections?
Will New User Fees Fuel More FDA Inspections?

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

Medical Device Industry

Will New User Fees Fuel More FDA Inspections?

Will New User Fees Fuel More FDA Inspections?

FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures

Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden

FDA 510(k) Approval Process Now Averages Over Six Months

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

FDA’s Shuren Works to Assure Device Industry Innovators

FDA Moves UDI Initiative Further Down the Production Line

Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation

Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR