In March 2022, and as part of their final guidance for voluntary recalls, the FDA urging the MedTech industry & companies to become more “recall ready”. The resultant increased scrutiny by the FDA over recalls has meant that in 2022, class 1 recalls hit a 15-year high, overseeing over 70 class 1 recalls. The numbers and extent of recalls within the MedTech industry speak for themselves- just in 2022, the industry saw almost 12,000 recalls, affecting over 62 million products worldwide and is certainly a burden MedTech organizations can no longer endure. Flexibility, tech-enabled and truly global solutions will become necessary to satisfy regulatory bodies, given the challenges to scale & support recalls by companies.

In this on-demand webinar, and given the unique nature of each recall, we explore & use practical examples how outsourced teams can augment existing models to relieve the internal burden & execute recalls quicker, more efficiently and compliantly.