A Small Manufacturer's Five Step Re-Think of ISO14971 for Design Control in the Post-Production Lifecycle of a Surgical Device

Transferring a safe and efficacious product into routine, capable, cost-effective operations is the goal of all product development teams. When transfer is complete and these teams go off to new projects, they count on risk management and surveillance data to signal when this goal is no longer being met. This is the signal to reconvene a multi-disciplinary team for troubleshooting. In alignment with the 2013 FDA strategic priorities, which include improvements to post-market surveillance and sharing systematic practices that go beyond compliance (see “The Case for Quality” [1]), this case study is presented to encourage a deeper discussion on the design of small enterprise practices for quality device commercialization. This case study examines a system in a single small enterprise. The device industry's recent regulatory flux (i.e. MDD Annex X, ISO14971:2012, ISO 14155:2011, MEDDEV 2.7/4:2010, MEDDEV 2.7.2:2008, MEDDEV 2.12-2:2012, MEDDEV 2.7.1:2009, GHTF SG5-N2:2007, GHTF SG5-N4:2010.) initiated this regulatory...