Updated to correct from CE Marking to EC Marking.
The Vancouver-based company said that as a result of the successful audit, and its maintenance of the ISO 13485: 2016 certification of its quality management system, it retained its EC Marking certification in the region.
“The quality system surveillance audits enables us to continue to advance our Reducer and Tiara programs by ensuring the safety, effectiveness and fitness for use of our devices, through risk-based effective and efficient processes and controls across the Total Product Life Cycle. The maintenance of the regulatory and quality certifications allows the team to be laser focused on achieving the 2019 goals and objectives for Reducer and Tiara programs,” quality VP John Panton said in a press release.
Neovasc said that its second surveillance audit is slated to occur next year.
On Monday, Neovasc priced an upcoming offering looking to raise $5 million to support its Tiara and Reducer devices.