Overview of FDA Requirements for Regulated Industries

A half-day professional training from Oregon Life Sciences covering the FDA regulatory landscape for medical device, diagnostic and biotech companies. The course maps the agency structure and authority, walks through the major submission pathways, and explains what compliance obligations attach at each stage of a product life cycle. Built for engineers, quality and regulatory staff, and technical founders who need a working understanding of the requirements before scaling a product or preparing a submission. Practical and discussion-oriented rather than certification-focused, with time for questions about specific product situations. Part of the Oregon Life Sciences fall technical training series held at its downtown Portland offices at 2130 SW 5th Ave, Suite 210. Registration and pricing https://www.oregonlifesciences.org/events/overview-of-fda-requirements-for-regulated-industriesoct6