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.
Ing. Kateřina Sedláčková
Direct support for these services
Premium product
For increasing the product attractiveness, competitiveness on the market and sales support
- Awarding license for the ESČ mark
- International product certification in the IECEE – CB system
- Certification of the quality management system in production
- Calibration of your instruments
Services for introduction to the market
Legislation
Qualifications
Services for introduction to the market
EZÚ offers the following services for the correct introduction of products to the market:
- Performance of tests electrical safety, electromagnetic compatibility, RoHS
- Exposure test reports
- Issuing the EZÚ certificate
- The assessment of technical documentation
- Certificate system certification referred to in Annexes government regulations and standards ISO 13485:2016
- Active implantable medical devices – annexes 2, 5
- Active medical devices – annexes 2, 5
- Inactive medical devices – Annex2, 5.
- Inactive implantable medical devices – Annex 2, 5
- ESC license
- CB certificate
- Tests of environmental effects – ingress protection, noise, vibrations
- Mechanical tests
Legislation
The Government Directive no. 54/2015 Coll. – Council Directive 93/42/EEC, 2007/47/EC for medical devices .
The Government Directive no. 481/2012 Coll.on the restriction of the use of certain hazardous substances in electric and electronic equipment.
Certification of quality systems in accordance with the ČSN EN ISO 13485:2012 standard.
Qualifications