You have designed an electro-medical device and you want to demonstrate the compliance of your device with the requirements of applicable Electrical and Electromagnetic Compatibility?
Demonstrating product compliance is not easy and engaging in trials with accredited laboratories without prior preparation can make you lose several months.
Nex’elec allows you to:
- Select the right service provider;
- Be supported in the preparation and implementation of tests in the best conditions;
- Work with a specialist who participates in trials and responds in real time to the expectations of the laboratory.
Nex’elec is a major asset to pass successfully the testing of electrical and electromagnetic safety, providing the test laboratory documents that comply with specific standards:
- A risk management file;
- Application of usability engineering file;
- A medical device designed in accordance with EN 60601-1 ed.3 and EN 60601-1-2 ed.4.0;
- Technical information about your products (in terms of electronic cards, list of critical components, certificate of RoHs, REACH…).
Nexialist’s experience on these missions makes it an ideal interlocutor between the customer and the testing laboratory.
Quickly demonstrating compliance with en EN 60601-1