Technical Regulations Consulting

TechniReg, Inc. provides consulting help in the areas of electrical product safety, EMI/EMC compliance, product development, quality systems, and documentation.  We specialize in performing work for the medical device industry and have experience with commercial products as well.

Electrical Product Safety and EMC

Our company provides a wide variety of services to help you comply with the various worldwide electrical safety requirements such as the IEC/UL/CSA versions of 60601-1, 60950-1, 61010-1 and the related particular standards including EMC. 

We work directly with the test agencies such as UL, CSA, Intertek, TUV, SGS and other NB/NRTL's to prepare the paperwork and interpret the Standards for you.  We can help you get that CE Marking for Europe or the mark of choice just for North America.

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 to the certification agency. We can even pre-screen your product using our own Hipot, Electrical Leakage and Ground Bond test equipment. 

Quality Systems

We can help update your quality system documentation to meet the requirements of ISO 13485 and the FDA Quality System Regulation (QS Reg. / GMP).  For commercial products we offer ISO 9000 assistance.  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 assist with ECR / ECO documentation processing, development of custom material specifications, resolving supplier quality issues, and 510(k) submissions, just to name a few.

Product Development

Need help with service manuals and product specifications, just ask.  We provide tech-writing, typing, and filing services.  We can assist you with new product development, mechanical and electronic design, and contract manufacturing through our network of trusted associates such as Design Analysis Consultants, Inc. (DACI).  

Let TechniReg be your ‘one-stop’ shop for all of your compliance and design needs.

 

 
 

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