Medical devices
Certification
The entrance ticket to the international medical device market is ISO 13485 certification. With our accredited ISO 13485 and ISO 27001 certification service, we provide internationally recognized certificates. In addition, we support our Clients throughout the certification stage with a Notified Body.
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Standard, legislation, guidance |
Description |
| ISO 13485 | Quality Management System |
| ISO 27001 | Information security management system |
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ISO 9001 ISO 14001 ISO 50001 ISO 45001 |
Management Systems |
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MDR IX., X. XI. IVDR IX., X., XI. |
Conformity assessmentUpon completion of above compulsory conformity assurance services theapplication for Conformity Assessment Procedure has to be placed at anindependent Notified Body. The list of eligible Notified Bodies can befound at the following links: MDR NB, IVDR NB |
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MD |
EC type - examination or certificate of conformity (CoC) of production equipment |
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LVD |
Certificate of conformity (CoC) of production equipment |
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EMC |
EC type - examination or certificate of conformity (CoC) |
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RED |
EC type - examination or certificate of conformity (CoC) |
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RoHS |
Certificate of conformity (CoC) |
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ATEX |
EC type - examination or certificate of conformity (CoC) |