Regulation, Safety & Quality

From prototype to approved device. Measurement uncertainty and calibration for verification, and medical-device regulation, risk management, software and usability standards, and IEC 60601 electrical safety.

• Measurement Errors, Uncertainty & Calibration — No measurement is exact. Learn gross, systematic and random errors, statistics of repeated readings, the GUM method for Type A and Type B uncertainty, combined and expanded uncertainty, propagation of uncertainty, traceability to national standards, calibration procedures (as-found / as-left, 5-point checks), calibration intervals, and test uncertainty ratio — with a real uncertainty budget in Python.
• Medical Device Regulation, Risk & Electrical Safety — Getting a device safely to patients. Learn device classification (FDA Class I–III, EU MDR I–III, CDSCO), regulatory pathways (510(k), De Novo, PMA, CE marking), quality management (ISO 13485, design controls, DHF), risk management (ISO 14971: hazards, risk estimation, ALARP, residual risk), software (IEC 62304) and usability (IEC 62366), electrical safety (IEC 60601: leakage currents, applied parts B/BF/CF, microshock vs macroshock), clinical evaluation and post-market surveillance — with Python for risk scoring and leakage current.