ISO 13485

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In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates^® (RCA) to cover the Medical Device quality standard ISO 13485 and why it is important for the industry.

Listen in as Jordan goes over the background of the ISO standard as well as some useful information companies can use when preparing to implement or update the standard.

He also touches on the current proposed industry request for comments by the FDA about QSR harmonization. If you would like to submit comments or schedule a meeting with Jordan to discuss these proposed changes, please use the contact us form at the bottom of the page or follow this link to our contact us page to set up a meeting.