Maxim Biomedical
Founded in 2005, Maxim Biomedical (MaximBio) is a leading diagnostic healthcare company enhancing global health through the development and manufacture of trusted diagnostic solutions. Our mission is to create diagnostic products that are affordable, accessible, and enable actionable testing to improve patient outcomes. Our technologies enable many of today`s leading diagnostic tests and we are proud to be at the frontline of diagnostic innovation to help advance the quality of healthcare.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Globally (various continents)
About us
- More than 5,500 square feet of clean lab space
- ISO 5, ISO 7, & ISO 8 Cleanrooms
- ISO 13485:2016 Certified
- FDA cGMP Registered
- FDA CFR820 Compliant
Quality
We are committed to our customer's success through a pledge to exceeding expectations. Our robust and flexible quality systems have been carefully designed to ensure that all the products we manufacture meet the highest levels of quality. Every product we manufacture is compliant to U.S. Food and Drug Administration (FDA) Good Manufacturing Practice and ISO13485 standards in our facility. Our team is experienced in manufacturing a wide range of Class I, Class II, and Class III medical devices and strive to achieve an industry leading standard of excellence.
Quality Management
We are dedicated to our customer's success through a commitment to exceeding expectations and delivering products with industry leading quality standards.
Since conception, Maxim Biomedical has been committed to meeting the highest standards of quality in the IVD industry. We have consistently maintained our quality system to be FDA registered, cGMP compliant, and ISO13485 certified for the last 15 years. Maxim’s dedication to quality is seen with our routine manufacture of CDRH and CBER regulated products. Our group of skilled developers, scientists, and professionals design and manufacture 510(k), PMA, and BLA regulated products each year. By utilizing our robust quality management system, Maxim is able to provide IVD products that are expertly developed, approved, manufactured, and delivered to market. Maxim handles every step of the IVD development process, from conceptualization to large-scale production. With our turnkey solutions and proven development and manufacturing process, our IVD products are made to ensure the highest level of quality.
Our commitment to quality is demonstrated through:
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USP Water Purification System
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24/7 Temperature & Humidity monitoring system
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Controlled Key-Access Security to all labs
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Annual audits conducted internally and by outside vendors/regulatory bodies
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Systematic lot release and lot traceability of all products and raw materials
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Validated manufacturing processes
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Manufacture 510(k) (Class I and II), PMA (Class III), and BLA products
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Familiarity and adherence with both CDRH and CBER regulation
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ISO 5, ISO 7, & ISO 8 Cleanrooms
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ISO 13485:2016 Certified
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FDA cGMP Registered
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FDA CFR820 Compliant