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MANAGEMENT SYSTEM CERTIFICATION: Medical devices
EZU has a long-term tradition and experience with certification of medical devices and evaluation of quality management systems at medical devices manufacturers and their suppliers. We offer you to lay hold on our experience, knowledge and technical equipment as well.
Our services comprise:
Quality management system certification according to standard (ČSN) EN ISO 13485:2003
EZU offers:
- Active implantable medical devices – Annex 2, 5.
- Active medical devices – Annex 2, 5, 6.
- Non-active medical devices – Annex 2, 5, 6.
- Non-active implantable medical devices – Annex 2, 5, 6.
Certification of medical devices distributors and service providers according to standard (ČSN) EN ISO 13485:2003 without parallel certification according to Directive – Government Order
The Electrotechnical Testing Institute, as a member of CQS – The Czech association of quality systems certification offers you:
- Certification services - certification audits and certificates granting
- EZÚ certificates and CQS and IQNet certificates - recognised in all five continents
- Situation and pre-certification management systems audits,
- Audits conducted in English, German and Russian languages.
Certification of medical devices manufacturers according to standard (ČSN) EN ISO 13485:2003 with parallel certification according to Governmental Order option
Cooperation at conformity assessment according to Act No. 22/1997 Coll. as amended:
- For Government Order No. 336/2004 Coll. in wording of GO No. 245/2009 Coll. – Medical Device Directive 93/42/EEC, 2007/47/EC
- For Government Order No. 154/2004 Coll. in wording of GO No. 307/2009 Coll. – Active Implantable Medical Devices 90/385/EEC, 2007/47/EC
Further see PRODUCT CERTIFICATION: Medical devices
Forms to be downloaded:
Contacts:
Ing. Kateřina Sedláčková
Medical devices, cables, conductors
266 104 289 603 223 412
ksedlackova@ezu.czCzech calling code: 00420
