Becky Fitzgerald has quality on her mind, and she wishes that more medical device manufacturers did, too.
In the industry, "there's a bit of a gap, if you will, between the compliance perspective" – device-makers wanting to...
Quality On The Brain: FDA Maturity Pilot Aims To Shift Industry's Compliance Mentality To A 'Quality Mindset'
An upcoming voluntary pilot program from US FDA will be the perfect vehicle to help drive a compliance-to-quality culture change at medical device firms, developers of the program say. To be stood up early next year, the pilot will see manufacturers use third-party assessors to measure the maturity of their quality systems and manufacturing processes. In a survey, early users of the Capability Maturity Model Integration (CMMI) appraisal process said it helped them identify ways to increase product quality.
More from Compliance
More from Policy & Regulation
• By
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
• By
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
• By
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.