QMS Certification for Medical Device Manufacturers
In assessing a quality management system (QMS), international standards and their national alternatives are applied. There are standards that allow assessing the QMS of any company regardless of its business area. For instance, the standards of the ISO 9001 series are widely used. Apart from general standards, there are also industry standards designed to assess the QMS of companies involved in specific lines of activities. ISO 13485 is an example of such industry-specific standard.
ISO 13485 is an international standard designed to assess the QMSs of manufacturers of medical products. GOST ISO 13485 is its national alternative in the Russian Federation.
Pursuant to Resolution No.46 issued by the Council of the Eurasian Economic Commission on February 12, 2016 setting out rules for registering and reviewing the safety, quality and effectiveness of medical products, QMS implementation and certification for conformity to standard 13485 is a mandatory requirement for manufacturers of medical products.
- The requirement to register medical products is mandatory within the EAEU;
- Increased trust in the products on the part of consumers and regulators;
- Ability to participate in tenders and procurement procedures initiated by major customers for whom ISO 13485 certificate is a mandatory requirement or advantage;
- Ability to build production processes in accordance with the model developed considering the peculiarities of the industry.
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