CE Marking for Medical Device, Automotive & Laboratory Equipment Manufacturers
As a medical device or laboratory equipment manufacturer, you have the need for Electromagnetic Interference (EMI) and Electrostatic Discharge (ESD) testing to achieve overall Electromagnetic Compatibility (EMC) and FDA compliance. It’s not economical to staff and maintain a full-time testing lab, so how do you test your products for FDA compliance? We suggest you employ the services of Midwest EMI, a testing laboratory whose primary focus is EMI/ESD/ISO testing for the medical, automotive and laboratory equipment industry.
For over 30 years, the experienced staff at Midwest EMI has succeeded by helping our clients find the most cost-effective approach to meeting compliance requirements. All testing is performed and reviewed by degreed engineers qualified to interpret data, resolve problems, and recommend design improvements. Midwest EMI is accredited by Nemko, Narte, and has a zero complaint record with the Better Business Bureau. We are an independent neighborhood lab with closely customized service for our clients.
Some of the Tests we Perform
- FDA IEC 60601-1-2 :2015 Medical Device Directive (MDD) & IEC 61326-1 (Lab Instruments)
- CE MARK (All Portions) – Conducted and Radiated Emissions, Conducted and Radiated Immunity, Electrostatic Discharge, Surge, EFT, Harmonics, Flicker, Voltage Fluctuations, magnetic and Electric Field tests, Transients Emissions
- FCC Part 15 & Cispr 32, Indoor Testing Underwriter’s Safety Tests – Leakage, Hipot, Grounding Impedance
- Automotive Testing – Most portions, ISO 7637-2 Road Vehicles: 2011(E) and ISO 16750-2, CISPR 25, Testing to 18 GHz
- Power Quality Testing using California Instruments 5001ix
Midwest EMI can test to any of the following power requirements:
- 120 VAC
- 400 VAC
- 440 VAC
- 480 VAC, both single and three-phase, 50, 60 or 400 Hz.
The 50Hz three-phase capability is up to 50 amperes. A California Instruments 5001ix 5000 watt arbitrary waveform generator is also available for generating complex power waveforms. 100 Volt per meter testing for automotive applications.
As testing costs continue to skyrocket, manufacturers are now facing a squeeze in the design phase to meet budget constraints. Midwest EMI fills a need as a matured and successful lab authorized under Nemko’s ELA program which qualifies our laboratory to the same ISO 17025 requirements as our competitors but without the baggage of bloated costs. We have a half-million-dollar equipment base to service your needs quickly and responsibly. Our test reports are easy to interpret and can be supplied in various formats such as softbound, pdf or CD.