CE marking guarantees safety and effectiveness
In June 2021, Henkaus reached a major milestone as it obtained the medical CE certification for its solution. Jayaprakash comments that obtaining the medical CE marking can be cumbersome, time-consuming and expensive for companies, but, at the same time, it guarantees the safety and effectiveness of the devices on the European markets.
“The CE marking certifies that our product is compliant with the relevant EU legislation and we are all set to commercialise our solutions anywhere in the European Economic Area,” he says.
Presently, Henkaus is making its devices in-house, but it’s starting to talk to contract manufacturers about larger-scale production.
“What we have now is basically a Minimum Viable Product capable of being sold in the market,” says Soumyajit Chatterjee, CTO & Co-Founder of the company.
“At this point, we want to educate the market and find as many early adopters as possible, first in the telemedicine market.”