Part I: US FDA Quality System Regulation Vs ISO 13485:2016
This white paper features an alignment chart that can be used to clarify the corresponding relationships between the US Food and Drug Administration (FDA) 21 CFR 820 and ISO 13485:2016 regulatory guidelines.
Use this tool to ensure your quality management system (QMS) meets the applicable requirements.
Download this free white paper to find out more.
For part II, click here.