Case Study: Avanos Automates Critical Quality Management Processes


In 2016, Avanos made the decision to adopt the Medical Device Single Audit Program (MDSAP). This program allows medical device manufacturers, like Avanos, to conduct a single regulatory audit of their quality management systems in order to satisfy the requirements of multiple regulatory jurisdictions. As an early adopter of MDSAP, the company needed to revisit its quality management strategy and processes in order to ensure compliance and quality excellence under this new system.

Avanos designed a unique audit Management module on Reliance that was specific to MDSAP and satisfied the requirements of all five jurisdictions.

Avanos Case Study