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CUSTOM ASSAY DEVELOPMENT & MANUFACTURE

Industry leaders in 

IVD development & manufacture for

government & private sectors

Trusted for over 25 years

Excellence in Design & Manufacture

Our team of dedicated professionals work in collaboration to create a custom-fit, full-service program in our state-of-the-art facilities to meet all of your needs and specifications. Even if you only have an idea or concept, our team at Maxim is ready to assist you with your design and take you through our established Development Program and into the market. Maxim's comprehensive in-house capabilities provide you with a world-class  experience and confidence in our ability to keep costs down and deliver your product on time.

MaximBio Capabilities

With over 50 years of combined industry experience, Maxim is led by management team members who provide oversight to our full-scale production organization. Our core group is made up of talent from all fields of medicine, chemistry, molecular science, domestic and international regulatory, and laboratory work. Our FDA cGMP approved and ISO 13485 certified facility combined with our dedicated, professional staff and proven quality assurance systems ensure production which measure up to the highest standards. 

As a premier CDMO, Maxim is prepared to help clients in all stages of assay development and manufacture from various sample sources. We recognize the uniqueness of each client's project and take our proven methodologies to identify, define, and provide an optimized solution to keep costs low and development times down. Our diverse team is highly experienced in all stages of product development, manufacture, and commercialization, resulting in an unparalleled level of service and technical support.

Maxim has helped numerous clients successfully develop and bring to market numerous medical devices, utilizing various technologies, including:

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Immunoassay

  • Lateral Flow (LFI)

  • Enzyme (ELISA)

  • Western Blot (WB)

  • Chemiluminescence (CLIA)

  • Recombinant ImmunoBlot Assay (RIBA)​

Molecular Diagnostics (MDx)

  • Real-Time qPCR

  • Isothermal Amplification

  • Generic Detection System

From concept to market, Maxim's development team of scientists and engineers is an industry leading source for assay development and custom manufacture of medical devices.

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Quality

Maxim's carefully designed FDA approved and ISO compliant quality systems represent the highest standards of quality and our dedication to our client's success through a mutual commitment to safety and innovative and cost-effective solutions. Our risk-based process approach from early product design through full-scale manufacture, ensures your product undergoes the strictest level of quality regulation. Maxim facilities are ISO13485 certified and FDA cGMP compliant to handle the manufacture of Class I, Class II, and Class III medical devices. Regardless of your specification, Maxim will adapt our Quality System to your needs. 

Quality Subsystems:

  • Dedicated Quality Management System (QMS)

  • Systems and Management Reviews

  • Design and Development

  • Process Validation and Performance

  • Production Quality Check integration

  • Assembly and Integration Processes

  • Internal Audits and CAPA System

  • Document Control

Certifications include:

  • FDA Registered and 21CFR Part 820 Compliant

    • Class I​, II, and III medical devices

    • 510(k), PMA, and BLA regulation

  • ISO 13485:2016 Conformance

 

Tell us about your project!

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