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Quality

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:

  • USP Water Purification System

  • 24/7 Temperature & Humidity monitoring system

  • Controlled Key-Access Security to all labs

  • Annual audits conducted internally and by outside vendors/regulatory bodies

  • Systematic lot release and lot traceability of all products and raw materials

  • Validated manufacturing processes

  • Manufacture 510(k) (Class I and II), PMA (Class III), and BLA products

  • Familiarity and adherence with both CDRH and CBER regulation

Certifications

  • ISO 5, ISO 7, & ISO 8 Cleanrooms

  • ISO 13485:2016 Certified

  • FDA cGMP Registered

  • FDA CFR820 Compliant