MDIC White Paper Aims To ‘Make CAPA Cool’
Executive Summary
A new white paper from the public-private partnership describes a framework that could make the corrective and preventive action process faster and more reliable.
You may also be interested in...
MDIC Quality Summit Unveils New Risk-Based Framework, ‘Safe Space’ Recall Initiative
During a recent summit, the Medical Device Innovation Consortium Case for Quality Collaborative Community introduced a new risk-based CAPA framework that moves away from the current compliance-focused “one-size-fits-all” approach to a more comprehensive strategy. The summit also discussed how the industry can more effectively and quickly notify consumers about recalls.
How A Team Led By Medtronic Quality Experts Plans To Stand Up To 'A Monster Called CAPA' – And Make It 'Cool'
The so-called "#makeCAPAcool" group wants to recast corrective and preventive action as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. A new voluntary CAPA framework developed by the team and piloted by a handful of device-makers will be rolled out later this year.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.