Design controls are a cornerstone of medical device quality management, providing a structured framework to ensure medical devices meet safety, efficacy, and regulatory standards. The overarching goal of design controls is to integrate quality into the design and development process.

In this eBook, we cover the evolution of FDA Design Controls (21 CFR 820.30), and take a look into:

• The 10 sections of FDA design controls
• Upcoming factors impacting design controls
• Aligning FDA’s new quality management system regulation (QMSR) with ISO 13485
• How Jama Software can help