An in vitro diagnostics (IVD) medical device and clinical lab organization with offices in the U.S. and Europe desperately needed a new QMS to better manage a vast quantity of paperwork. Beyond the risk of non-compliance, it was a daily challenge to ensure that procedures were standardised and the latest documents were being referenced.

How we Saved a medical device company time, compliance headaches and money

Posted on Posted in Case studies, General, JIRA

For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely manner becomes impossible – and threatens to derail a busy, successful international organization for non-compliance.  The challenge  An in […]

RadBee Sophia Genetics Case Study

From Paper-Based to practical: How we digitised a paper-based QMS & ensured ISO-27001 compliance in just 5 weeks

Posted on Posted in Case studies, Confluence, Electronic QMS

An efficient quality management system (QMS) is the lifeblood of any company in the health industry. Failure to meet strict regulatory and compliance requirements could mean lost business or even a complete shutdown of operations. The challenge Biotech start-up SOPHiA GENETICS has had a QMS in place since its launch six years ago. VP of […]