The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the process, teams generate more robust evidence and stronger submissions, which often means a shorter approval process.
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
A look into the importance of high-quality software in the medical device industry.
When assessing the root cause of a use error, look at the user interface before pointing fingers.
Many product development teams use root cause analysis and root cause corrective action to identify the origin of defects in their development processes and prevent them from recurring. Though these can be complicated and time-consuming, automated product development solutions can help reduce the time spent on RCA, RCCA, code reviews, and other quality improvement efforts.