What You Need To Know About ISO 13485 And 21 CFR Part 820

By James Jardine, MasterControl

All medical devices share one commonality: when produced by companies that follow the medical device quality management standard ISO 13485, they're aiming for the highest globally recognized standard of quality. With the impending harmonization of ISO 13485 and 21 CFR Part 820 just around the corner, the standard is further cementing its global importance and ubiquity.

If your organization plays a role in the development of a medical device, a quality management system (QMS) that meets ISO 13485 requirements doesn't just happen. It takes a concerted organizational effort, thoughtful planning, and a thorough understanding of the work required for compliance. Below you'll find answers to some of the questions commonly asked by companies striving for compliance with ISO 13485 requirements.