- The quality system for medical devices (UNE-EN ISO 13485:2018) thus adds to the certificates Envera holds for its surgical masks and the manufacturing authorization by the AEMPS.
- The masks can be purchased through the WEB Envera Shop.
Madrid | July 30, 2021
Envera has received the medical devices quality management system certificate in accordance with the UNE-EN ISO 13485:2018 standard. Specifically, the report refers to the manufacture of surgical masks type IIR for medical use (class I) that Envera carries out in its Special Employment Center in Colmenar Viejo (Madrid). Thanks to this service, which has been authorized by the Spanish Medicines Agency (AEMPS) since May 2020, Envera offers a high quality product while creating eight jobs for people with disabilities during the pandemic.
The certificate, issued by the OCA Global Certification Institute, is in addition to those that Envera already holds and that accredit the performance requirements and test methods of this product to limit the transmission of infectious agents (UNE-EN 14683: 2019 + AC: 2019) as well as to certify the test method for resistance to penetration of synthetic blood in masks as protection elements against infectious agents (ISO 22609:2004).
Envera's Spanish-made surgical mask manufacturing machine, with a production capacity of 120 units per minute, meets the demand for this product from customers and large companies that rely on the services offered by this non-profit organization.
The innovative production of masks is part of the new business lines(Envera kits and clean room packaging) that Envera has launched to reduce the dramatic impact of the crisis caused by COVID-19 and to continue advancing in the social and labor inclusion of people with disabilities, especially intellectual disabilities, who work in its special employment centers.
It should be remembered that with Envera, companies, in addition to contracting quality products and services at the best price, contribute with their social responsibility to the maintenance of jobs for people with intellectual disabilities and compliance with the General Law on Disability, in addition to acquiring a strategic social value that makes them more competitive organizations.
You can support Envera's social work by purchasing the surgical masks type IIR as well as other COVID-19 protection material at the Envera Shop on-line store or at Envera Inclusion Point: Islazul Shopping Center (Madrid), Carrefour Ciudad de la Imagen (Pozuelo de Alarcón) and Carrefour Prat (El Prat de Llobregat).
