Defymed ISO 13485 :2016

Communication TuvSud

Defymed is proud to announce the certification transfer of its quality management system according to ISO 13485 :2016 standard to TüvSüd.
Since the beginning of the quality management system commitment, Defymed’s strategy was to identify and select one notified body for both ISO certification and CE marking. For that, the notified body has to be designated by its national designating authority according to scope codes set out by the European Commission. The European Commission is notified by the designating authority for renewal decision taken considering designation.
After the publication of the new Medical Device Regulation (MDR) identified as 2017/745, Defymed had to verify if its current notified body will apply and be designated for certification activities. Unfortunately, Defymed’s former notified body decided to maintain ISO 13485 certification activities but not to apply for MDR 2017/745. As a result, since end 2019, Defymed prospected to select a new notified body that will be designated for this new regulation.
After prospection, TüvSüd was the most reactive and corresponding notified body according to their field of expertise and the scope codes for which they are designated and that cover both Defymed’s medical devices (ExOlin® and MailPan® are both soft tissue implantable medical devices, class III). That is why, Defymed started discussions with TüvSüd in 2020. After several feedbacks, the adopted strategy to transfer Defymed’s ISO certificate without a “no certified period” was the following:
–         Have a “pre-transfer audit” based on Defymed’s documentation, and an on-site audit,
–         Ensure the renewal audit by Defymed’s former notified body,
–         Send the renewed certificate and audit report established by Defymed’s former notified body to TüvSüd in order to establish the new certificate stamped by TüvSüd.
At this date, Defymed is officially certified according to ISO 13485: 2016 with both TüvSüd and its former notified body until 2023. To ensure Defymed’s conformity with ISO 13485 standard, surveillance audit will occur in 2021 and 2022 and a renewal audit in 2023 by TüvSüd.
This certification is a real added value for Defymed to convince investors, customers and patients of the good practices applied in the company; even more, if the notified body has a worldwide reputation!