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  • Feature ArticlesFeature Articles

    Recasting CAPA as a continuous improvement process

    This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.   Introduction Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a stru...
  • Regulatory NewsRegulatory News

    CDRH’s Case for Quality Pilot Gains Momentum

    The pilot program led by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aimed at manufacturing and product quality has gained momentum this year, with dozens of waived post-approval and risk-based inspections among participating firms.   The pilot program is collectively run by CDRH and the FDA-funded public-private partnership Medical Device Innovation Consortium (MDIC) and the CMMI Institute under CDRH’s 2014 Case for Qua...
  • Regulatory NewsRegulatory News

    CDRH Touts Uptick in Foreign  Device Inspections

    The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report.   “As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries,” said Jeff Shuren, director at the FDA’s Center for Devices and Radiologi...
  • Regulatory NewsRegulatory News

    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...