The Electrotechnical Testing Institute has a long tradition and experience in the certification of medical devices and verification of the quality management systems of their manufacturers and suppliers. We offer you the opportunity to take advantage of our experience, knowledge and technical equipment as well
The EN ISO 13485:2003 standard was published as a harmonized standard for the European Directives 93/42/EEC and 90/385/EEC in the Official Journal of the European Union, which enables its use to demonstrate conformity with the requirements of these European Directives.
The ČSN EN ISO 13485:2016 standard was prepared in view of the higher demands placed on the quality management systems of the suppliers and manufacturers of medical devices. The ČSN EN ISO 13485:2016 standard defines criteria for the entire scope of the quality management system for medical devices.
A certificate issued in accordance with the the ČSN EN ISO 13485:2016 standard covers the whole management system of an organization producing or supplying medical devices and related services.
We offer certification of quality management systems in accordance with the ČSN EN ISO 13485:2016 standard for:
- Active implantable medical devices – annexes 2, 5
- Active medical devices – annexes 2, 5, 6
- Non-active medical devices – annexes 2, 5, 6
- Non-active implantable medical devices – annexes 2, 5, 6
- showing a commitment to fulfilling legislative and regulatory requirements
- guarantee of the stability of the production process and thus the stable and high quality of services and products provided to customers
- proving the suitability, effectiveness and efficiency of the established quality management system by an independent third party
- improving the quality of the management system, enhancing the organizational structure of the organization
- improving order and increasing efficiency of the entire organization
- cost optimization – reduction of operating costs, reduction of costs for nonconforming products, savings in raw materials, energy and other resources
- increasing the trust of the public and state supervisory authorities to the manufacturers of medical devices
- Certification of the quality management system in accordance with the ČSN EN ISO 9001:2009
- Certification of the information security management system in accordance with the ČSN ISO/IEC 27001
- Certification of the IT service management system in accordance with the ČSN ISO/IEC 20000-1
- Certification of the environmental quality management system in accordance with the ČSN EN ISO 14001:2005
- Certification of occupational health and safety management in accordance with the ČSN OHSAS 18001
- “Quality and Safe Erection” quality mark
- EMAS III – Verification of environmental declarations in accordance with Directive (EC) no. 1221/2009 of the European Parliament and the Council