Technical Regulations Support
Our mission is to help small and large businesses with regulations governing electronic products. We call these "Technical Regulations" and that's why our company is named TechniReg.
We provide specialized help in the areas of electrical product safety, EMI/EMC compliance, product development and documentation. We have completed projects for the medical device industry as well as for commercial products.
Electrical Product Safety and EMC
We can provide a wide variety of services to help you comply with the various electrical safety requirements such as the IEC/UL/CSA versions of 60601-1, 62368-1, 61010-1 and the related particular standards including EMC.
We work directly with the test agencies such as UL, CSA, Intertek, TUV, Eurofins/MET Labs, SGS and other NRTLs (Nationally Recognized Testing Laboratories) to prepare the paperwork and interpret the Standards for you. We can help you get that Electrical Safety mark of choice.
Don't set yourself up for failure at the test lab! During the design phase, we can preview your product for potential problems and recommend compliant design solutions before you submit for certification testing. We can pre-screen your product using our Hipot, Electrical Leakage and Ground Bond test equipment.
Quality Systems
Note that NRTLs require a minimal quality system even for non-medical and commercial products in order to pass their factory inspections. Therefore it makes sense for us to be involved in Quality Systems.
If your business does not yet have a Quality System, we can help you implement one using the most appropriate method for your type of business.
We can help update your quality system documentation to meet the requirements of ISO 13485 and the new FDA Quality Management System Regulation (QMSR / GMP). For commercial products we offer ISO 9000 assistance.
We can assist with ECR / ECO documentation systems, development of custom material specifications, and resolving supplier quality issues, just to name a few.
Product Development
Need help with service manuals and product specifications, just ask. We can help with new product development, mechanical and electronic design, and contract manufacturing through our network of trusted associates.
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