Electromagnetic Compatibility (EMC) is a testing program with a primary goal of identifying the sources of electromagnetic energy emitted from an electronic device in an effort to reduce potential interference to other equipment, as well as determining the susceptibility of the equipment from electromagnetic energy emitted by other electronic devices nearby.
SubCon Manufacturing Corporation has completed this testing on its medical device products, demonstrating compliance with the requirements of Electromagnetic Compatibility (EMC), Parts 3-2, EN 61000-3-2 & E lectromagnetic Compatibility (EMC), Part 3. EN 61000-3-3.
Underwriters Laboratories Inc. (UL) / Canadian Standards Association (CSA)
UL is a product safety testing organization and is certified as a Nationally Recognized Testing Laboratory (NRTL) with US, Canadian, and global product safety certifications.
SubCon Manufacturing Corporation has completed the safety testing on its medical device products, demonstrating compliance with the appropriate safety requirements. This compliance and testing to UL Standard 60601-1, Medical Electrical Equipment , Part 1; General Requirements and Canadian Standards Association (CSA), Medical Electrical Equipment, Part 1; General Requirements for Safety, Standard C22.2 No. 601.1-M90 allows the medical products manufactured by SubCon Manufacturing Corporation to display the familiar UL / CSA marking .
Food and Drug Administration (FDA)
The FDA is a Federal agency within the US that governs the public health by assuring the safety of products through evaluating the benefits and risks of their intended use and by auditing the manufacturer’s quality program for compliance.
SubCon Manufacturing Corporation is a Registered Company with the Food and Drug Administration with products in the medical device category. SubCon Manufacturing Corporation's quality system is compliant to the requirements of 21 CFR Part 820 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule.
This U.S. industry comprises establishments primarily engaged in loading components onto printed circuit boards or who manufacture and ship loaded printed circuit boards. Also known as printed circuit assemblies, electronic assemblies or modules, these products are printed circuit boards that have some or all of the semiconductor and electronic components inserted or mounted and are inputs to a wide variety of electronic systems and devices.