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MDIC Quality Summit Unveils New Risk-Based Framework, ‘Safe Space’ Recall Initiative

 
• By Brian Bossetta

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.

Summit
• Source: Shutterstock

Making any regulatory matter “cool” may seem impossible, especially in the realm of quality assurance. But not according to Kathryn Merrill, global quality program director at Medtronic. For the last five years, Merrill has led an initiative from the Medical Device Innovation Consortium (MDIC) with the goal of changing the way device industry views corrective and preventative actions (CAPA) — or, making CAPA cool.

Launched in 2018, #makeCAPAcool is an attempt to improve CAPA strategies by recasting the often-arduous process as part of a risk-based strategy of continuous quality improvement. (Also see "MDIC...

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