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

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

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 [...]

The 2nd Driver of the Foundry Model and how it’s shaping the Molecular Diagnostics Industry

By |February 27th, 2018|Cost, Manufacturing, QA/QC|

Part Two- Leveraging Commonality The second driver that spawned the growth of the foundry model was the ability to Leverage Commonality. By the mid 1980’s, the techniques used to manufacture a wafer and eventually a semiconductor chip were largely co [...]

Looking to Gain Value in Your Drug Product or IVD? Level-Up Your QC Program

By |February 8th, 2018|Cost, QA/QC, Useful Tips|

Many organizations view their QC program as a necessary evil- required by regulatory bodies and useful primarily to release product. However, defining and building a solid Quality Control program can unlock great value. Setting aside the need for fin [...]

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 [...]