Case Study: Molecular Loop accelerates ISO 13485 readiness with ZenQMS

Molecular Loop Prepares for Iso 13485 Certification With Help From Zenqms

Molecular Loop, a life science tools research and manufacturing company, needed to build an ISO 13485-compliant quality management system as it brought manufacturing in-house to support new pathogen-monitoring and genetic testing applications. The company chose ZenQMS after finding other eQMS options too cumbersome and difficult to use, and wanted a system that would be easier to implement and validate.

With ZenQMS, Molecular Loop implemented a flexible, pre-configured eQMS that supported document control, change control, validation, risk assessment, and user acceptance testing. ZenQMS helped the team move quickly with less than half of one employee devoted to the software side of QMS implementation, while improving professionalism, support, and readiness for inspection as Molecular Loop prepares for ISO 13485 certification.

Molecular Loop

Greg Porreca

Chief Executive Officer