When a recall occurs the Regulatory Agencies such as the FDA require communication that is timely about corrective actions being taken by companies that FDA may consider have high-risk products. These actions can include removing products from the market, correct the products or even update instructions for use. We will discuss recall scenarios and risk management strategies that can be employed with a focus on lot release, sterility and safety. Additionally, the key areas Device Inspections will focus on for products that have been recalled. In addition, how can companies prepare for inspections by having robust recall procedures in place as well as preparing key high risk areas for compliance.
This is the second presentation from day 3 of the live 3-day virtual symposium hosted through the Sotera Academy where Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device. Click here to watch all of the presentations on the Sotera Academy or fill out the form on this page for access.