Spectrum Solutions Company Profile
Qualifications: ISO 13485, FDA Registered, CGMP Certified, Demonstrated experience in the medical device or IVD space
Markets Supplied: Worldwide
Spectrum Solutions, a life science company, focuses its fully integrated industry expertise on creating forward-looking end-to-end solutions for clinical diagnostic projects and commercialized product plans. Spectrum is a single-source provider for innovative medical device engineering & product manufacturing, molding, formulation, packaging design, customized kitting, & direct-to-user fulfillment.
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...
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IRP Medical
San Clemente, CA USAQualifications: ISO 9001, ISO 13485, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide