Case Studies

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

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

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 Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely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 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....

read more
Digitising paper QMS & ensuring ISO-27001 compliance

Digitising paper QMS & ensuring ISO-27001 compliance

The challenge of digitising paper 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. Improving and digitising paper QMS can be a key part of modernising your process and fulfilling various compliance requirements. Biotech start-up SOPHiA GENETICS has had a QMS in place since its launch six years ago. VP of Quality Jasmine Beukema and her team work hard to ensure that SOPHiA has always met the medical device...

read more