• Via Matteucci, 10 – 50041 Calenzano (FI) - Tel. 055 8827323 – Fax 055 8839756
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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