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About Us

MPS Medical, Inc. (MPS) is a privately held medical device company located at 785 Challenger Street, Brea, CA 92821, USA, an FDA registered facility conveniently located in Orange County, Southern California. MPS has more than 30 years’ experience in the field of design, development, manufacture, and distribution of a variety of medical devices.


MPS is committed to providing exceptional medical device manufacturing services and high-quality diagnostic products, at reasonable prices, to help improve health throughout the US. In recent years of effort in combatting the COVID-19 pandemic, MPS has deployed state-of-the-art high speed production machines to manufacture large quantity of rapid antigen test kits and other similar medical devices for different kinds of diseases or diagnostic needs with strong adherence to ours and customers’ Quality Management Systems.

Manufacturing and Warehouse Facility

Infrastructure


  • Over 30,000 sqft FDA registered facility
  • 3,000 sqft ISO Class 8 cleanroom (CEPA certified) with temperature & humidity-controlled RH ≤ 30%
  • 18,000 sqft temperature-controlled warehouse
  • Compressed air: Max 600 CFM @100 psi, Class 0 air quality
  • Electrical supply: 800 A @ 480 V

Manufacturing Capability


  • Cutting-edge automated production machines for rapid antigen test kit manufacturing in certified clean room, up to 250k kits per shift.
  • Production quality controls such as force test, leak test, test kits mechanical & diagnostic performance.
  • On-site quality control and product release capabilities.

Warehouse Equipment & Capability


  • One automated box packaging machine
  • Three conveyor belts for improved packing and transportation efficiency
  • Capability to fulfill 10,000+ orders per day

Regulations Compliance

Subject to the product’s design and development plans, MPS’s quality management system complies with the following standards and regulations:


  • ISO 13485 Quality systems – Medical devices – Quality management systems –Requirements for regulatory purposes
  • US FDA 21 CFR Part 820, Quality System Regulation
  • ISO 14971 Medical Devices, Risk Management

    © 2023 MPS -All Rights Reserved.

    Technology Supported by MPS

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