Quality &
Regulations

We pay close attention to changes in standards and regulations. Anticipating them ensures the durability of our business and its openness to new markets.

SERF’s commitments

 

In order to sustain our quality approach based on standard NF EN ISO 13485: 2016 of Directive 93/42/EEC relating to medical devices (amended by Directive 2007/47/EC) and the requirements of 21 CFR Part 820, SERF complies with regulatory requirements and ensures that its quality management system remains effective. SERF’s quality management system is certified by notified body GMED, which issues the CE mark for our medical devices. In 2017, SERF was awarded GMP (Good Manufacturing Practice) certification from ANVISA.

Please contact SERF for information concerning the regulatory status of products.