Understanding your Medical Product Testing Needs

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Medical Products of the future will focus on wireless applications along with a faster, more accurate and reliable means for capturing data and images. MRI, CAT Scans and Sonograms will have better, faster and more integrated results. In addition, the FDA has not only required that medical equipment be immune to cell phones and ambient signals, but also that medical products have lower susceptibility limits overall. To accommodate these changing needs, Ingenium Testing, has extensive facilities and equipment designed for medical products including a Reverberation Test Chamber, Wireless Certification Services and Mil-Standard Testing for special applications. We also have expert engineering consultation available for medical product development, modification and production. If your product is used in a medical office, healthcare facility or transport vehicle, our lab has the ideal test environment to ensure your product’s certification.
 



 



Medical Product Test Capabilities


  • United States / Canada and European Union

    Medical Product Testing is driven in the United States by the FDA / CDRH 510(k) filing process and in the European Union by the Medical Device Directive (93/42/EEC). Canada requires a Quality Management Certificate in accordance with ISO 13485:1996 or ISO 13488:1996.


  • All of the above apply to the following EMC Test Standard:

IEC / EN 60601-1-2 Medical Electrical Equipment-Electromagnetic Compatibility-Requirements and Tests