Pascall Systems, Inc.
Early-stage medical device company developing a wearable brain monitoring system spun out of research at Massachusetts General Hospital and MIT. Activities described include development of signal-processing and machine-learning algorithms, hardware/firmware engineering, device validation and testing, and implementation of quality management systems aligned with FDA and ISO standards.
Industries
Nr. of Employees
small (1-50)
Pascall Systems, Inc.
200 Portland St, Boston, MA 02114
Products
Wearable brain monitoring system (under development)
A next-generation wearable device platform for monitoring brain-related physiological signals intended for use in patient care; development includes hardware, firmware, signal processing and validation under regulated quality systems.
Wearable brain monitoring system (under development)
A next-generation wearable device platform for monitoring brain-related physiological signals intended for use in patient care; development includes hardware, firmware, signal processing and validation under regulated quality systems.
Services
Development, testing and regulatory validation of signal-processing and machine-learning algorithms for physiological data under a quality management system.
Hardware architecture, prototyping, firmware development and functional testing for wearable medical devices.
Support for implementing and maintaining quality management processes (document control, CAPA, training) in alignment with ISO 13485 and FDA QSR.
Processing and analysis of physiological and clinical metadata for research and device development, including causal and statistical analyses.
Development, testing and regulatory validation of signal-processing and machine-learning algorithms for physiological data under a quality management system.
Hardware architecture, prototyping, firmware development and functional testing for wearable medical devices.
Support for implementing and maintaining quality management processes (document control, CAPA, training) in alignment with ISO 13485 and FDA QSR.
Processing and analysis of physiological and clinical metadata for research and device development, including causal and statistical analyses.
Expertise Areas
- Wearable brain-monitoring device development
- Biomedical signal processing and analysis
- Algorithm validation under regulated quality systems
- Medical device hardware and firmware engineering
Key Technologies
- Electroencephalography (EEG)
- Electromyography (EMG)
- Electrodermal activity (EDA)
- Real-time signal processing
News & Updates
Job posting describing quality systems and operations internship with responsibilities for ISO 13485 and FDA QSR–aligned activities.
Job posting describing hardware, firmware and testing responsibilities, laboratory equipment usage and IEC standard exposure.
Job posting describing statistical and biomedical signal-processing, machine learning, real-time processing and experience with clinical datasets.
Public FCOI policy document describing disclosure, review, monitoring and reporting requirements for investigators on PHS-funded research.
Job posting describing quality systems and operations internship with responsibilities for ISO 13485 and FDA QSR–aligned activities.
Job posting describing hardware, firmware and testing responsibilities, laboratory equipment usage and IEC standard exposure.
Job posting describing statistical and biomedical signal-processing, machine learning, real-time processing and experience with clinical datasets.
Public FCOI policy document describing disclosure, review, monitoring and reporting requirements for investigators on PHS-funded research.