How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016

By |June 26th, 2019|Certifications, QA/QC, Tips and Tricks|

For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food and Drug Administration (FDA) has considered their Quality System Regulation (QSR) to be the minimum criteria for medical device manufacturing since [...]

Argonaut Receives Device Manufacturing License from California Food and Drug Branch (FDB)

By |August 22nd, 2017|Certifications, News and Announcements|

Argonaut Manufacturing Services is pleased to announce that it has received a device manufacturing license from the State of California Department of Public Health Food and Drug Branch. This licensure, together with Argonaut’s FDA registration and IS [...]

Argonaut Announces ISO 13485:2016 Quality Certification Achievement

By |March 1st, 2017|Certifications, News and Announcements, Press Release, QA/QC|

Argonaut Manufacturing Services, a contract manufacturing organization (CMO) dedicated to serving the life science and molecular diagnostics markets, announced today that it has received ISO 13485:2016 certification following a successful inspection [...]