Qualified support during the certification and compliance verification process

  • Design and production processes according to ISO 9001 and ISO 13485 standards

  • Management of technical files and interaction with Notified Bodies and Accredited Testing Laboratories

  • Assistance during quality audits of clients and Notified Bodies.

  • Large instrument fleet for pre-compliance, validation and measurement

Pre-compliance workshop

Pre-compliance workshop

We provide qualified support during verification of compliance with regulatory, documentary and performance requirements for each product.

Documentazione esecutiva, documenti di progetto

Technical file management

We draft technical files in full or in collaboration with clients.

We strictly follow the regulatory requirements for each product.

  • Analysis of essential requirements.

  • Risk Analysis for Medical Machines and Devices.

  • Sizing for Intrinsic Safety in the ATEX and IECEx areas.

  • Life cycle of medical software according to EN 62304.

  • Usability verification.

  • Management of labeling requirements and EU Declaration of Conformity.

  • Drafting of operator manuals.

Strumentazione di prova, camera climatica

Test instrumentation

We have specific instrumentation for testing compliance with harmonized standards, including:

  • Dielectric strength.

  • Insulation resistance.

  • Leakage currents.

  • Thermal and climatic tests.

  • Ball impact tests.

  • Precision, contact and IR surface temperature measurements.

Strumentazione EMC pre-compliance

EMC Instrumentation

We have a fleet of instruments for EMC pre-compliance testing and other types of testing to harmonized standards. We are able to perform testing according to standards including:

  • Conducted Emissions (EN 61000-3-2)

  • Voltage dips (EN 61000-4-11)

  • Electrical Fast Transients (Burst, EN 61000-4-4)

  • Surge (EN 61000-4-5)

  • ESD (EN 61000-4-2)

  • Conducted Immunity (EN 61000-4-6)

  • Verification of radiated emission sources

Strumentazione di misura

Measuring instrumentation

We have complete and verified measurement instrumentation for analysis and validation of each product.

  • Handheld and benchtop multimeters, current clamps.

  • Oscilloscopes with contact, differential, current probes.

  • Stabilized power supplies.

  • DAQ for signal analysis and analog measurements.

  • Function generators.

  • Calipers and dial gauges.

  • Thickness gauge, torque meter.

  • Phonometer, luxmeter.

  • Scales and dynamometers.

  • Precision contact and non-contact temperature sensors and loggers

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Accomplished Projects

Explore some of the products made by Ennebi

Unità terminale remota RTU

Remote terminal unit (RTU) for remote control of power grids

Peripheral Unit (UP) for remote control of power grid – indoor mounting

Sistema di alimentazione e backup per telecontrollo

Power supply and backup system (PSBC2020L) for power grid telecontrol systems

Segnalatore lampeggiante stroboscopico

Flashing strobe beacon

Unità di Elaborazione 8 canali

8-Channel Processing Unit (UE8) for remote control of power grids

Termoregolatore a celle termoelettriche

Thermoregulation system using TEC cells

System-on-module (SOM NB342)

Sistema alimentazione e backup multi sorgente

Multi-source power and backup system (PSBC2020RES) for power grid telecontrol systems

Alimentatore flyback compatto ad elevata efficienza

Power system with single-stage PWM-PFC topology

System-on-module (SOM NB434)

Peripheral Unit (UP) for remote control of power grid – outdoor mounting

Unità di Elaborazione a 16 canali per telecontrollo

16-Channel Processing Unit (UE16) for remote control of power grids

Three phase DIN rail power supply 750/1000W

DIN rail power supply 150/250W

Adattatore Vac su presa automotive

Vac power supply adapter with 12Vdc output to ANSI/SAE J563 automotive socket

Alimentatore per sistemi di pesatura

Low-noise output power supply for weighing systems

System-on-module (SOM NB228)

System-on-module (SOM NB290)

Single phase DIN rail power supply 750/1000W

Ballast a bassissima tensione

Ballast system for fluorescent lamps with 12-24Vdc input

Adattatore Vac per dispositivi a batteria

Power supply input Vac – output connector rechargeable battery module

Sistema di controllo per diodi laser medicali

Control and drive system for medical laser diodes

Three-phase DIN-rail power supply 360/500W

DIN rail power supply 50/75/100W

Sistema alimentazione e backup

Power supply and backup system (PSBC2020) for power grid remote control systems

Single-phase DIN-rail power supply 360/500W

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