Spectrum Solutions

Description

Since 2006, Spectrum Solutions has been a single-source provider of high-quality, direct-to-consumer product innovation & global fulfillment. For the last decade, Spectrum has found a specialized focus in the medical science sector that includes the engineering and manufacturing of industry innovating medical devices. Spectrum's innovation has made such an impact within the life science sector it has been honored with several prestigious awards, received incredible industry and private sector recognition, and is directly responsible for the birth of a new billion-dollar saliva diagnostic industry. Because we engineer and manufacture our own medical devices, actively participate in medical science research programs, develop, and license diagnostic testing assays, we are uniquely equipped to offer contract manufacturing customers the stand-alone or integrated full development-to-delivery solutions that quickly expand specialized testing programs, advance medical device development, and support More... new healthcare-at-home business commercialization growth opportunities. FDA Registered Medical Device Organization, ISO 13485 certified, cGMP Compliant, Spectrum is regularly audited by federal and industry officials to ensure compliance with stringent federal regulations such as 21 CFR Part 820. We manufacture medical products for various regulatory jurisdictions, including the US (FDA), Europe (CE), Health Canada, and APAC region. These include low-risk to higher-risk IVDs and medical devices using the FDA's cGMP standards. Our proven expertise, innovative products, and support processes are elevating standards and pioneering a new era of specialized testing solutions from personalized health & wellness to molecular diagnostics.

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