Compatible Electronics, a leading testing service provider, specializes in evaluating and testing medical electrical devices to ensure compliance with various standards, including AAMI 60601-1:2012, IEC/EN 60601-1, and IEC 60601-1-2 Ed. 4.0. The company's expertise extends to other medical device standards such as IEC 61010-2-101. With FDA ASCA certification and NVLAP accreditation, Compatible Electronics offers efficient testing processes and reliable reporting to streamline FDA submissions.
By partnering with Compatible Electronics, clients can benefit from efficient delivery and reporting, flexible lab scheduling, access to the latest regulations, technical design consulting, prompt project commencement, and competitive quotations. The importance of Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI) testing for medical devices cannot be understated, as it ensures that devices do not cause interference or abnormal clinical data. Through EMI/EMC testing, potential issues are identified, and compliance with standards such as CISPR 11/EN 55011 is assessed.
Compatible Electronics provides a comprehensive range of EMI/EMC and safety testing services for medical electrical devices. This includes EMC pre-compliance scans to identify problem frequencies, measurement of radiated emissions to determine compliance with specific limits, radiated immunity testing to assess RF proximity fields, and electrostatic discharge (ESD) testing according to IEC 61000-4-2 standards.
Compatible Electronics is equipped to handle the testing needs of various medical devices. Their expertise in medical device mechanics and regulatory requirements allows them to provide quick and cost-effective validation and verification services. The company ensures that medical devices adhere to EMC testing standards, covering areas such as power frequency magnetic fields, harmonics, flicker, surge, conducted and radiated immunity/emissions, and more.
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