MPS Medical was established in January 2021 in the State of California to become a manufacturer of medical devices. Having acquired technology, suppliers, distributors, customers, and most employees from Acacia Inc., MPS Medical has been an FDA-registered facility since its inception.
- Cleanroom ISO Class 8 with Humidity controlled ≤30 % RH
- 3,000 sqft Cleanroom (CEPA certified) and 18,000 sqft Warehouse facility
- Compressed air Supply:
- Max 600 CFM @100 psi Class 0 Air Quality
- Electrical supply:
- 800 A @ 480 V in the facility
- 12 Rapid Test Kit Manufacturing Machines
- 1 Force Test System
- 1 Shipping Box Packaging Machine
- 3 Conveyor Belts
Subject to the product’s design and development plans, the Company’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
- MPS operates under one Quality Management System (QMS), focused on meeting or exceeding regulatory and customer requirements, as well as continuous improvement. Our Quality Management System supports the business objective of providing “quality products/services, on time and within budget” to our customers.
- The use of advanced engineering, manufacturing, and information technology is the engine driving us towards our quality goals. Only by a commitment from the whole company to continually improve our business and the way we serve customers; will we fulfill our strategic objectives.
Quality Management System
Our Quality Policy
- MPS has detailed quality policies and procedures for management responsibility and authority that define requirements and responsibilities. The organization and the interrelation of personnel who manage, perform, and verify work affecting quality within each facility are defined in the quality policies and procedures. Ultimately, the President of MPS Medical is responsible for establishing, implementing, and maintaining the company-wide quality management system. The President is also responsible for appointing the Management Representative. The Management Representative reviews compliance to the MPS Medical Quality Management System at Management Review Meetings and maintains the records of the reviews.
- MPS Medical is committed to continuous improvement. MPS Medical company-wide metrics include Quality Objectives and are defined in company-wide quality policies and procedures. Regular metrics performance review meetings are held to drive process improvement efforts. Annual improvement goals are established with corresponding process improvement plans as a part of Management Review Meetings.
- A quality function has been established and is maintained under the direct supervision of QA/RA to perform the quality management system activities outlined in the MPS Medical Quality Manual and company-wide and/or facility quality procedures.
- MPS provides sufficient suitably designed buildings, equipment, and supporting services such as IT, PM, etc., to perform all operations necessary to meet product requirements and prevent unintended uses.
- Planning of new, and/or modification of existing infrastructure and facilities are usually conducted in conjunction with product or process changes, capacity and/or workforce expansion, and other such events. Facilities may be expanded or modified to improve the ease of maintenance, product quality, process efficiency, or the work environment.
- Maintenance of building, facilities, and equipment is performed on a routine basis. This includes regularly scheduled maintenance of production equipment, lighting systems, air conditioning and heating systems, landscaping, and cleaning. Repairs of buildings, equipment, and other facilities maintenance may be contracted to outside service providers.
- Records of maintenance activities, including inspections to assure adherence to maintenance schedules, are maintained.
- Controlled environmental requirements for manufacturing areas are suitable for the class of risk of devices being manufactured.
Monitor and Control
Control of Monitoring and Measuring Equipment
MPS has detailed quality policies and procedures for the control of inspection, measuring, and test equipment that delineate requirements and responsibilities. This includes customer supplied equipment. Calibration may be performed by an approved subcontractor qualified to perform equipment calibration. Where necessary to ensure valid results, measuring equipment will:
- Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification will be recorded.
- Be identified to enable the calibration status to be determined.
- Be safeguarded from adjustments that would invalidate the measurement result.
- Be protected from damage and deterioration during handling, maintenance, and storage.
Control of Nonconforming Product
- MPS Medical has detailed quality policies and procedures for control of nonconforming product that delineate requirements and responsibilities. Nonconforming product is controlled to ensure that product that does not conform to specified requirements is prevented from unintended use or sale. This control provides for the identification, documentation, evaluation, segregation, and disposition of nonconforming product. Functions affected by nonconforming product are identified and notified.
- Records of the nature of nonconformities and any subsequent actions taken will be maintained.
Monitoring and Measurement of Processes
Monitoring and Measurement of Product
- Inspection and testing activities are performed to verify that the specified product requirements are met. MPS Medical has detailed quality policies and procedures for inspection and testing that delineate requirements and responsibilities. Inspection and test requirements, and associated records, are specified in quality plans and quality procedures.
- Incoming product is not used or processed until inspected, tested, or otherwise verified, and it has been determined that the product meets specified requirements. Receiving inspection requirements are based, in part, on the amount of control exercised by the subcontractor and the inspection records provided. Product may not be shipped until all required inspections have been completed.
- In-process inspections are performed in accordance with established quality plans and procedures. Product is held until required inspections and tests have been performed and recorded, except when urgently needed for production and conditional release is required.
- Final inspection and testing are performed in accordance with established quality plans and procedures to verify that the finished product meets specified requirements. All inspection and testing requirements are completed, documented, and acceptable prior to authorization of release of product for shipment.
- Records of inspections and tests performed, test results, identification of person(s) performing inspections and tests, and any non-conformances detected are maintained as specified in quality procedures.
Measurement and Analysis
- MPS has detailed quality policies and procedures for the measurement and monitoring activities required to ensure product conformity, to facilitate continuous improvement to processes and the quality management system, and to assure continued effectiveness of the quality
- Sampling plans must utilize appropriate statistical methodologies. When changes occur to products or processes, sampling plans will be reviewed.
- Measurement and monitoring activities to ensure and verify product conformity are defined in engineering specifications and drawings, work instructions, inspection and testing procedures, and process control procedures.
- MPS Medical will include review of monitoring, measurement, and analysis data of Quality Indicators; Non-Conformance, Returned Goods Authorization, Customer complaints; Internal/External audit observations, Corrective and Preventive actions; Calibration Out of Tolerance and will perform a risk analysis to identify the risk and take action to mitigate the issue.
- MPS Medical deploys a continual improvement philosophy throughout the organization, and the efforts are focused on the goals in the quality objectives and quality policy. Improvement opportunities are identified by analyzing quality performance data and information. Improvement projects are defined and implemented through the system of corrective and preventive action and management review.
- Corrective and preventive actions taken are recorded and followed to ensure they have been properly implemented and are effective.
- If a customer complaint is not followed by corrective and/or preventive action, the reason will be authorized and recorded.