The FDA recently issued a proposed rule laying out the plan for the long-awaited ISO 13485 & Quality System Regulation (QSR) Harmonization. This proposed rule comes 4 years after FDA's first signal that they intended to overhaul 21 CFR 820 to be more closely aligned with the international standard. Join us as we breakdown all details of the plan, including key areas for firms to focus on within the rule, what the medical device regulatory landscape will look like after implementation, analysis on financial impact to firms, and more.
Learning Objectives:
The key areas for firms to focus on as the FDA looks to harmonize the QSR with ISO 13485
How to prepare your team and business to ensure you are ready for the harmonization