Cirdan has successfully passed its recent surveillance audit for the Medical Device Single Audit Program (MDSAP), ISO 13485:2016 and ISO 9001:2015. Due to the ongoing pandemic this audit was held remotely with our Notified Body, BSI, which presented a new challenge for the team.
We are delighted to have completed this and to have been positively recommended for re-certification. Cirdan continues to strengthen and improve its Information Security & Quality Management System to ensure ongoing success and compliance.
More on MDSAP
Cirdan successfully achieved MDSAP certification last year for its Quality Management System (QMS). MDSAP is mandatory in Canada, with companies that are not MDSAP compliant no longer able to sell medical devices there with the other participating countries USA, Australia, Japan and China expecting to follow thereafter. MDSAP enables medical device manufacturers to fulfil the requirements of these participating regulatory authorities through a single audit.This certification further demonstrates Cirdan’s commitment to continuing to embed a strong quality culture and solid foundation for global market growth and further strengthens our QMS for the future within this heavily regulated industry.