Case for Quality
Leading Quality Excellence Across the Device Lifecycle
In 2011, the FDA launched the Case for Quality program to support manufacturing practices that are of consistently high quality and also align with the laws and regulations implemented by FDA. Since 2014, FDA has worked with the MDIC and other stakeholders to foster an elevated level of collaboration between the agency and the medical device industry and to launch initiatives that vary from traditional oversight models.
Enhanced product quality helps hospitals, payers, healthcare providers, and patients to be confident that the devices they rely on will perform as intended. Predicting and managing the right risks can also enable device manufacturers to reduce costs and increase profits by focusing on quality throughout the entire product lifecycle. Simply put, an investment in quality has long-term payoffs.
Program Background
Upon an in-depth review of device quality data and feedback from regulatory and industry stakeholders, the FDA’s analysis flagged manufacturing quality risks, leading to the launch of the Case for Quality program in 2011. Findings also showed that firms that manage those risks by driving quality organization-wide are more productive, with fewer complaints and investigations per batch, and often with smaller quality units with lower quality-related costs than their competitors. A cultural shift of this magnitude demanded the engagement of regulators, industry, providers, payers and patients, and so the Case for Quality movement found a new champion in MDIC.
