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Rose Medical has been certified to ISO 13485 since 2008.  Our most recent ISO certificate: 

Rose Medical is a registered manufacturer with the United States Food and Drug Administration (FDA).  FDA Registration Number: 1836324

As part of our ISO certification we have defined our Quality Policy in our Quality Policy Manual.

As a contract medical device manufacturer, we get audited frequently.  To reduce the needed on-site time for an audit we are happy to provide digital procedures and records to be reviewed in advance of the audit.  To request these documents, you can contact the process engineer for your project or e-mail your request to info@rosemedical.com