Serres Oy received MDSAP (ISO 13485:2016) certificate
Serres Oy is pleased to announce that we have received certification for the successful completion of a Quality Management System audit under the Medical Device Single Audit Program (MDSAP).
MDSAP certificate exemplifies Serres’s ability to design, develop and manufacture safe and effective medical devices that meet the highest quality and safety standards set by the regulatory authorities.
MDSAP programme is recognised in 5 countries; Australia, Brazil, Canada, Japan and the USA. The programme is voluntary for the other countries except Canada,
manufacturers who sell medical devices (Class 2 or higher) into Canada after 1st January 2019 must have a QMS that has been approved through the MDSAP programme.
In order to continue the sales of Serres suction bag system in Canada Serres was obliged to be part of the MDSAP programme. The scope of the Serres MDSAP certificate was extended to all five countries.
The MDSAP programme is based around adherence to the Quality Management Systems Standard for Medical Devices ISO 13485: 2016 along with additional requirements from the five participating countries. MDSAP does not apply to Europe, which currently only has observer status in the MDSAP programme, so MDSAP programme is not replacing our regular QMS-audit according to ISO 13485.