Erik Henau, chief executive officer at UK- based Women’s Healthcare company Concepta (LON:CPT), discusses the ISO13485 accreditation the group received for its myLotus fertility product with Proactive Investors, ahead of targeted commercial launch in the UK and Europe in the second half of this year.
"It is the first step in achieving compliance with the European regulatory requirements," he says. "On the one hand it's a key approval of what we do and how we do it, the consistency in all operations, and quality throughout the organisation, but it is also a requirement if you want to sell medical devices."
"It is really key for an organisation to achieve this, and in the short time since we have gone through the AIM Market which was at the end of July. So it has been a record achievement for our small start-up business," Henau points out.