Quickly demonstrating compliance with en EN 60601-1

I have to demonstrate the compliance of my electro-medical device with EN 60601-1 ed.3 in a very short time and in order to sell it worldwide. How can I do so?

With Nex’elec, our team takes care of it for you:

  • Select the testing laboratory that will be able to carry out tests on time and be able to pass a test report from recognised authorities;
  • Re-draft in a clear and concise manner the requirements of EN 60601-1ed.3 and support you in the construction of the expected documents;
  • Anticipate the demands of the laboratory and ensure that the existing documentation is adequate;
  • Liaise with the technicians of the testing laboratory to facilitate exchanges and understand their expectations;
  • Build documentation or complete missing information (notice, risk management file, fitness-for-service file and search for RoHs certificates…);
  • Participate in testing to facilitate the processing of potential bottlenecks.

Result of Nex’elec for your business:

  • Simplification of the administrative procedures involving the testing laboratory;
  • Good responsiveness to questions from the testing laboratory;
  • Documentation in line with European and international requirements;
  • A significant decrease in the response time to customer teams, already overloaded;
  • Obtaining a certificate and a test report on time.

Risks of poor anticipation of the certification process:

  • Testing can be stopped repeatedly because the product and / or the proposed documentation did not demonstrate product compliance;
  • Testing may last for several months due to various interruptions;
  • The report may not be recognised by all authorities

Our solution

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