SMETA l SEDEX Audit Certificate
The relevant document shows that we are among the SEDEX members who have successfully completed the 4-Pillar SMETA audit and are able to demonstrate corporate development in the fields of labor rights, health and safety, environment and business ethics, quality and traceability in production.
FDA EUA
The relevant certificate is the certificate showing that you are on the EUA (Emergency Use Authorization) list which is published by FDA connected to United States Department of Health. For a detailed report, contact us at info@muskmedikal.com.
TÜV
The relevant certificate is the certificate showing that the product meets the EN 149: 2001 + A1: 2009 standard as a result of the inspections and tests carried out by TÜV, which is an independent audit, control and certification body with a history of more than 140 years authorized by the German State for technical inspection, controls and management system certification in Germany. For a detailed report, contact us at info@muskmedikal.com.
TÜV HYGIENE AND CHEMICAL TEST
The relevant certificate is the certificate showing that the product has successfully completed all of the chemical tests performed in 9 different parameters. For a detailed report, contact us at info@muskmedikal.com.
INTERTEK TEST REPORT
The relevant certificate is the certificate showing that the product meets EN 149: 2001 + A1: 2009 standard by İntertek, based in England, is one of the most reliable assurance, inspection, product testing and certification companies in the world with more than 1000 laboratories and offices in more than 100 countries with a 136-year history. For a detailed report, contact us at info@muskmedikal.com.
MNA CE MODULE B
The relevant quality certificate is the initial approval certificate showing that the product is in FFP2 class. For a detailed report, contact us at info@muskmedikal.com.
MNA CE MODULE C2
The relevant quality certificate is the certificate showing that the product is continuously made its surveillance through testing and that it has successfully completed the process. For a detailed report, contact us at info@muskmedikal.com.
ISO 9001:2015
ISO 9001 Quality Management System is a standard that expresses an effective quality management system. Organizations that meet the requirements of this standard may obtain ISO 9001. With this certificate, an organization shows that the goods and services it manufactures and provides to its customers are produced in accordance with an internationally accepted standard.
ISO 13485:2016
ISO 13485 is a quality management standard that can be applied to medical device manufacturers with the title of requirements for regulatory purposes, published by the ISO institution.