Physiological signals — electrocardiogram (ECG), electroencephalogram (EEG), electromyogram (EMG), respiratory signals, and the photoplethysmographic signals captured by today’s wearable devices — are the raw material of much of modern medical-device development. Behind every cardiac monitor, ambulatory ECG patch, sleep tracker, and pulse oximeter sits an algorithm that acquires, conditions, and interprets a physiological signal. For engineers, software developers, regulatory professionals, and clinical specialists entering the field, the first task is to develop a working vocabulary and a working intuition for how those signals behave.

This 16-hour Professional Certificate Course is the entry point of the Aleph Biomedical Signal Analysis course track. It introduces sampling theory, the Discrete Fourier Transform (DFT) and the Fast Fourier Transform (FFT), the basics of digital filter design, and the publicly available physiological-signal datasets (PhysioNet, MIT-BIH Arrhythmia Database, Sleep-EDF) used as references in the field. The course also orients participants to the regulatory framework that surrounds the deployment of signal-processing algorithms as medical-device software functions — IEC 62304 software lifecycle, the FDA Software as a Medical Device (SaMD) framework, and the FDA Software Functions premarket guidance (June 2023).

The course is designed to prepare participants for the Advanced level (BME-540-A), where the same methods are exercised at applied depth — adaptive filtering, wavelets, QRS detection benchmarking, machine learning, and the FDA AI/ML Predetermined Change Control Plan (PCCP) framework. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the vocabulary, the intuition, and the orientation that the medical-device industry expects of someone entering a signal-processing or SaMD role. Employers in this space include medical-device manufacturers (cardiac rhythm management, neuromonitoring, ambulatory monitoring, wearables), digital-health and consumer-health companies whose products are regulated as SaMD, contract research organizations, and regulatory-affairs consultancies that support clients with software-driven submissions. The Introductory level is the right starting point for professionals whose work touches physiological signals but who do not yet have a working command of the underlying methods.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.