New FDA QMSR: Its Role In Part 4 Compliance For Combination Products

The FDA’s release of the new Quality Management System Regulation (QMSR) significantly revises 21 CFR Part 820 Quality System Regulation and, in turn, Part 4 CGMP for combination products. The inclusion of ISO 13485 through reference brings the impact of global harmonization efforts to your doorstep, regardless of your organization’s role in the industry or its geographic jurisdiction.