Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
Now Respinor is closing in on becoming a manufacturer of non-invasive medical devices for monitoring of respiratory function. The Norwegian medtech company completed the Stage 1 Audit with Lloyds Registry Quality Assurance (LRQA) on, January 15, 2018.
LRQA found no non-conformities during the Stage 1 audit.
Audit in Stage 2 is scheduled for May 2018. Certification to ISO 13485:2016 will in turn facilitate Respinor obtaining the CE Mark on its device. It will secure enrolment into the clinical programs, preparing the manufacturing of their non-invasive medical devices for monitoring of respiratory function.