Medical devices are one of the products regulated by the FDA. The US Food & Drug Administration (FDA) is an agency within the Department of Health and Human Services, a government agency that establishes and publishes regulations that govern the sale of various products to protect and promote public health.
The FDA requires that manufacturers establish and maintain quality systems to ensure that their products meet the usability and safety needs of their customers. Quality systems for products that are governed by the FDA are based on Good Manufacturing Practices or GMP’s. The GMP compliance requirements for medical devices are outlined in the Code of Federal Regulations (CFR):
The PST product range can help comply to the FDA 21 CFR Part 820 Quality System Regulation, Subparts G and M.
Subpart G – Production and Process Controls
The Rotronic Monitoring System (RMS) is a real time environmental monitoring system designed for GxP applications that can help monitor critical process parameters and other parameters to ensure product quality. The PST teams worldwide can offer support in terms of service, calibration, for control and monitoring equipment, and calibration procedures as well as system validation based upon the GAMP®5 recommendations.
Subpart M – Records
RMS is a FDA 21 CFR Part 11 conform software solution that offers full data integrity for record purposes. As the environmental monitoring is part of the device history and quality system it is crucial that these records are maintained during a minimum of 2 years from the date of release for commercial distribution by the manufacturer.
The ISO 13485 Quality Management for medical devices is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry and aligns with the FDA 21 CFR Part 820.
However, an ISO is only a guideline and not a regulation and as of such is not mandatory but does offer various benefits such as demonstrating compliance with regulatory and legal requirements and ensuring the establishment of QMS practices that consistently yield safe and effective medical devices. RMS helps fulfil the following ISO 13485 requirements:
PST can also offer monitoring solutions to comply to the ISO 14644 standards for cleanrooms and associated controlled environments.
The Gateway is the interface between the wireless data logger and the server software.
Flexible data logger
Flexible data logger
Data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement.
Very low current consumption, the highest accuracy, and measurement results within 90 ms
Autonomous operation on failure.
The sensor holder is traceable end-to-end and meets all FDA and GxP environments.
The RMS-TCD-S-001 is a completely digital designed probe for the Rotronic Monitoring System RMS. It measures temperature.
The RMS-LOG-T30 is a data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The development of legionella in drinking water lines can be prevented by avoiding stagnations, a temperature range of 25 °C to 55 °C and biofilms on the insides of the pipes.
Data logger with two integrated analog-to-digital converters to which two sensors can be connected for high-precision analog measurement.
NDIR 技术测量二氧化碳的模拟探头
The Rotronic differential pressure probes are ideal for clean rooms, operating theaters and applications where even minor differences in pressure can have a big effect.
The RMS-HCD-S digital probe is characterized by its high performance.
The Gateway is the interface between the wireless data logger and the server software.
The flexible dataprotection component of the Rotronic Monitoring System RMS
Data logger with two integrated analog-to-digital converters