The EEC Directive 93/42 and EC 2007/47 requires a complex process for achieving the CE marking of medical devices, both in terms of product conformity and production processes. In this field Elettra s.r.l. has been working successfully for a long time in:
- Identification of standards and technical-regulatory application
- Laboratory compliance testing according to harmonized standards; test reports are recognized by notified bodies for EEC Directive 93/42 and CE 2007/47 as being issued by accredited laboratory according to EN 17025 from Accredia
- Checking of the Technical File
- Voluntary certification for Class I devices
- Quality assurance in design / production
- Testing in production stage