Creating
healthier communities
through
innovative & accessible
Point-of-care (POC)
& in vitro diagnostic (IVD) tests
About Us
Founded in 2005, as a branch of the Maxim family, Maxim Biomedical was created as a company dedicated to the development of high quality, in-vitro diagnostic (IVD) and Point-of-Care (POC) testing solutions that make positive contributions to public health and healthcare worldwide. Our location, in Rockville, MD, places us in one of the world's top scientific regions; just steps away from our nation's capital. Customers can purchase from our existing line of FDA or CDC approved products, select from our raw materials, or opt-in for our customized CRO/CMO services. Whatever needs you have, Maxim has tailored it’s products and services to meet them.
OUR FACILITY - BY THE NUMBERS
26,000
SQ FT FACILITY SPACE
13+
INDIVIDUAL LABS
OVER
25
YEARS OF EXPERTISE
More than 5,500 square feet of clean lab space
ISO Certified Class 100 – 1,000 Clean Rooms
Dry rooms totaling more than 1,700 square feet
Equipped with fully automated machinery for:
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Striping
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Laminating
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Cutting
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Buffer Filling
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Assembly of Rapid Tests
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Packaging of Rapid Tests
A Commitment to Quality
Our rigorous quality assurance procedure have been carefully designed to ensure that your products are produced exactly to your specifications every time. Every Maxim product is manufactured according to U.S. Food and Drug Administration (FDA) Good Manufacturing Practice and ISO13485 standards in our facility. We are dedicated to our client's success through a mutual commitment to safety, innovative and cost-effective solutions, continuous improvement, and to maintaining the effectiveness of our quality and regulatory systems. Our ISO13485 certified and FDA cGMP compliant facilities are capable of manufacturing Class I, Class II, and Class III medical devices. Regardless of your specification, Maxim will adapt our Quality System to your needs.
Quality Subsystems:
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Dedicated Quality Management System (QMS)
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Systems and Management Reviews
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Design and Validation Performance and Processes
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Production Quality Check integration
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Internal Audits and CAPA System
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Document Control
Regulatory Compliance:
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FDA Registered and 21CFR Part 820 Compliant
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Class I, II, and III medical devices
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510(k), PMA, and BLA regulation
-
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ISO 13485:2016 Conformance
For copies of our regulatory or product certificates, please contact Quality@mbidiagnostic.com.
Join Our Team
Our team at Maxim prides itself on the innovative work and positive impact we create on global health everyday. We are always looking for dedicated and ambitious individuals looking to help us grow.
Maxim Biomedical is a proud equal opportunity employer.
Need more details? Contact us
We are here to assist. Contact us by email or phone!