Lund, Sweden, April 7, 2020. Gedea Biotech, an innovative women’s health company today received its certificate in accordance with ISO 13485: 2016 (Medical devices - Quality management system - Requirements for regulatory purposes). The scope of the certificate includes design, development,marketing, distribution and production of antibiotic-free vaginal tablets intended to treat bacterial vaginosis. The certificate has been issued by TÜV SÜD, an accredited notified body.The ISO-certificate is a part of the company’s development towards a CE-marking of a product. Therefore, the ISO certificate is a very important step towards CE marking of pHyph, ensuring that Gedea´s quality management systems in design, development, marketing, distribution and production are sufficient.
Annette Säfholm, Gedea Biotech’s CEO comments: “I am delighted that we have now reached this important milestone as planned. The certification is a major step forward towards CE marking and launch of our vaginal tablet, pHyph for treatment of bacterial vaginosis. Gedea plans to apply for CE marking of pHyph, according to MDR, during 2020.”
There is currently a noticeable shortage of notified bodies designated for the new EU regulation MDR (Medical Device Regulation) and many medical device companies are struggling to have their products approved in time. Gedea chose to work with Tüv Süd over two years ago, as Tüv Süd was one of the first notified bodies to become designated for MDR.