Regulatory clearance and manufacturing
We are ramping up manufacturing to serve our first pilot customers.
After having received CE regulatory clearance for the Vital Sign Monitor as a class 2a medical device end of last year, we have recently also passed the annual ISO 13485 surveillance audit for Biovotion and our manufacturing and supply chain.
This is another important step towards a broader commercialisation of Biovotion’s Everion and data analytics solutions in an evolving regulatory environment.
For Biovotion it is the beginning of an exciting journey in the field of digital health with our expandable, secure platform benefiting patients, users and institutional stakeholders in an increasingly consumerising healthcare arena.
Our next milestone is the first FDA registration to also fully serve the US market.