Medical Devices

  • Directive 93/42/EEC
  • Directive CE 2007/47

Directive 93/42/EEC and CE 2007/47 involve a complex path towards achieving CE marking for medical devices, involving both product and manufacturing process compliance. In this context, Elettra s.r.l. has established its presence over time by successfully operating in the following areas:

  • Identification and application of technical regulations
  • Execution of conformity tests in the laboratory, according to harmonized standards; test reports are officially recognized by notified bodies for directives 93/42/EEC and CE 2007/47, being issued by an EN 17025 accredited laboratory by Accredia
  • Verification of the Technical File
  • Voluntary certification for Class I devices
  • Quality system verification in design/production
  • Execution of production tests and trials

The experience and efficiency demonstrated by Elettra s.r.l. are essential to ensure compliance with current regulations and the quality of manufactured medical devices.