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-risk to higher-risk IVDs and medical devices using the FDA’s cGMP standards.
Spectrum’s all-star team of medical, design, engineering, and manufacturing experts leverage the ideal combination of Six Sigma, Lean Manufacturing, Theory of Constraints, and FEMAs to deliver the products and services crucial in supporting a global healthcare system.
The advantages of aligning with the right project partner mean the best combination of industry-innovating products, specialized services, and tailored solutions supporting fast project successes. There is no substitute for medical industry experience or certifications. We focus our expertise on every detail, so you don’t have to.
Turnkey, Scalable, High-Performance Thermoplastic Molding & Rapid Tooling Experts
Fully integrated Contract Manufacturing for Complex Medical Devices and Components
Saliva Diagnostics Adds Highly-Valuable Benefits – A Better Diagnostic Tool
Medical Device Development & Engineering