FDA Case for Quality has three priorities for addressing the barriers to quality that were identified. One of these priorities is Focus on Quality. FDA and Case for Quality stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes.
Many of the challenges medical device manufacturers face when designing products are familiar to all manufacturers, some are unique to the medical device industry. Medical device manufacturing is a commercial activity. When done correctly, the products can have a very positive impact on individuals or whole populations.
Medical device manufacturing is a highly regulated activity. Some manufacturers may be dealing with one regulator or multiple regulators. In this webinar, Seabrook discuss in the context of FDA, 21 CFR 820. The FDA definition of Design Controls states that each manufacturer is required by regulation to establish and maintain design control procedures for any class III or class II device, and a selected group of class I devices. The design control procedures ensure that specified design requirements are met.
To learn more, click here to request a recording of the presentation.