Certification

Macopharma has developed and implemented
a quality management system to better satisfy the needs of its customer
and to improve the management of the company.

The quality system complies with the international standards
NF EN ISO 13485:2016 and regulatory requirements.

It covers design, manufacture and distribution of medical devices for the processing and storage of blood, cells, organs and tissues, the collection of biological fluids and the servicing of medical devices.

CE Certificates

All of our medical devices feature the CE marking and meet the fundamental requirements of European directive 93/42/EEC.

The CE certificates are available on request.

Some of our blood filtration systems are approved by the United States Food and Drug Administration (FDA).

ISO Certificates

Macopharma is certified ISO 13485: 2016 by the notified body Gmed.

The certificate covers each production site.

See the certificate

MDSAP certificate

In addition to the ISO 13485, Macopharma is certified under the MDSAP program for the following countries : Australia, Brazil, Canada and USA.

See the certificate