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PRODUCT CERTIFICATION: Medical devices
EZU has long time tradition and experience with testing and certification of medical devices and quality management systems assessment at medical devices manufacturers and their suppliers. Lay hold on our experience, knowledge and technical equipment.
Our services comprise
Products conformity assessment according to the Act No. 22/1997 Coll. as amended:
- For Governmental Order No. 336/2004 Coll. in wording of GO No. 245/2009 Coll. – Medical Device Directive 93/42/EEC, 2007/47/EC
- For Governmental Order No. 154/2004 Coll. in wording of GO No. 307/2009 Coll. – Active Implantable Medical Devices 90/385/EEC, 2007/47/EC
Quality management system certification according to Governmental Order Annexes and ČSN EN ISO 13485:2003 standard
- 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.
Medical devices testing and measurement – conformity with Governmental Order Annexes
- Tests - Active implantable medical devices – Annex 3, 4
- Tests - Active medical devices – Annex 3, 4
Tests and measurement of medical devices
- Single tests
- Tests for demonstration conformity with standard
- Self tests using special testing equipments from EZÚ test laboratory
Worldwide certification systems – tests of active medical devices according to IEC and EN standards – additional service to the CE certification
Contacts:
Ing. Kateřina Sedláčková
Medical devices, cables, conductors
266 104 289 603 223 412
ksedlackova@ezu.czCzech calling code: 00420
