The worldwide increasing need of uniform regulatory requirements resulted the development of a medical standard that can be applied by a full range of medical device manufacturers and which guarantees the safety and satisfactory performance of medical products.
In accordance with the Regulations (EU) 2017/745 and (EU) 2017/746 medical device manufacturers are required to implement and maintain an effective quality assurance system.
The application of EN ISO 13485 standard is voluntary for medical device manufacturers, at the same time in a significant part of the medical device market it is an unavoidable requirement to prove the existence of a quality management system.
The standard EN ISO 13485 describes the essential requirements for the quality management system of a medical device manufacturer.
By complying with the standard, the organization can demonstrate its permanent ability to produce medical devices that meet legal requirements and fulfil the intended purpose and to provide related services.
In many cases, the EN ISO 13485 standard is the only way for suppliers of medical device manufacturers to prove compliance with the relevant requirements.
The EN ISO 13485 certification is essential not only in the European market but also worldwide.
For QM system certification request download and fill out the Quotation form EN ISO 9001/EN ISO 13485 and submit your application to cert@emki.hu e-mail address.
Accreditation
The NEOEMKI LLC. is accredited by the National Accreditation Authority for certification of QM systems according to EN ISO 13485 standard.
The scope of the accreditation is described in the deed of accreditation. The up-to date accreditation status can be checked on the National Accreditation Authority homepage (www.nah.gov.hu).
Certificates
For detailed information on the validity of issued EN ISO 13485 certificates send an e-mail to titkarsag@emki.hu e-mail address.
The list of suspended and withdrawn certificates is regularly updated and published.