Medical devices

EZÚ offers services for:

  • Active implantable medical devices
  • Active medical devices
  • Non-active medical devices
  • Non-active implantable medical devices
Announcement of changes by the manufacturer to the certificate HERE.
Photo of Ing. Milan Šantrůček
Ing.MilanŠantrůček
Manažer produktu
Phone+420 266 104 261Cell phone+420 603 223 415

Direct support for these services

Premium product

For increasing the product attractiveness, competitiveness on the market and sales support I am interested in this service
Services for introduction to the market
Legislation
Qualifications

EZÚ offers the following services for the correct introduction of products to the market:

  • Evaluation of conformity – for medical devices in classification class I
  • Evaluation of conformity by a notified body – for all the other classification classes
  • Conducting tests of electrical safety, electromagnetic compatibility, RoHS
    • active implantable medical devices – annexes 3, 4
    • active medical devices – annexes 3, 4
  • Issuing test reports
  • Issuing the EZÚ certificate
  • Evaluation of technical documentation
  • Certification of quality systems in accordance with the annexes of the Government Directive and ČSN EN ISO 13485:2012 standard
    • 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

We also offer: