MDSAP certification

The certification company DQS Medizinprodukte GmbH granted Synthesia the MDSAP certificate, which demonstrates compliance with the ISO 13485 standard and at the same time with the regulatory requirements of countries involved in the Medical Device Single Audit Program (MDSAP). In the case of our OKCEL haemostats, conformity with the requirements of Canada, Brazil and the USA was assessed. The award of the certificate will allow us to more quickly enter these markets where traditional regulatory oversight can cause significant delays. The advantage of the program is also a reduction in the number of on-site inspections by regulatory authorities.


Certifikát MDSAP