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