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-risk to higher-risk IVDs and medical devices using the FDA’s cGMP standards.
The benefits of partnering with Spectrum Solutions include the best combination of industry-innovating products, specialized services, and tailored solutions supporting quick project success. There is no substitute for medical industry experience or certifications. We focus our expertise on every detail, so you don’t have to.
Contract Manufacturing & Outsourcing
- Medical Product Design, Development, CAD and Concept Prototyping
- R&D Scientists and Engineers Including Quality, Design Controls, and Process Validation
- Injection Molding & Expert Tooling with Rapid Prototyping Capabilities
- Microfluidics Chemical Formulation Development
- Custom Packaging, Unique Barcode Serialization, and Specialized Kitting
- Direct-to-User Global Fulfillment with SaaS biosample chain-of-custody & customizable track-and-trace notifications
Precision Medical Device Molding & Manufacturing
- Concept Design & Engineering
- State-of-the-Art Facility
- Dedicated Clean-Rooms
- Fully-Electric Medical Molding
- Precise Metrology Lab
- Skilled Mold Validation
- Prototype & Expert Tooling
- Medical Device Redesigns
Specialized Healthcare & Direct-to-Consumer Packaging
- Medical Device Packaging
- Packaging Consultation
- Structural Engineering
- Custom Designed Artwork
- 3D Mockup & Prototyping
