Learn to develop real medical devices from concept through post-market surveillance — device classification and regulatory strategy, ISO 13485 quality systems, ISO 14971 risk management, biomaterials, biomechanics, biosignal processing, medical imaging, sterilization, human factors, software as a medical device, clinical trials, and the applied domains of cardiac devices, neural devices, prosthetics, and drug delivery.
20 modules and 5 complete real-project deliverables, with worked calculations and a certificate of completion.
FDA Class I/II/III, 510(k) vs. PMA vs. De Novo, and regulatory strategy as a day-one design input.
ISO 13485, design controls, the Design History File, document control, and CAPA.
The full ISO 14971 process — hazard analysis, risk control hierarchy, residual risk, and benefit-risk analysis.
Material classes — metals, polymers, ceramics — and the ISO 10993 biocompatibility framework.
Stress and strain in bone and soft tissue, stress shielding, fatigue analysis, and implant load analysis.
ECG/EEG/EMG origins, instrumentation amplifier design, and noise/artifact rejection.
X-ray/CT attenuation contrast, ultrasound pulse-echo, and MRI proton relaxation.
EtO, gamma, and steam sterilization, sterility assurance level, and sterile barrier packaging validation.
IEC 62366, use-related risk analysis, and formative/summative usability testing.
SaMD classification, IEC 62304 software lifecycle, and cybersecurity basics for connected devices.
Clinical study design for devices, IDE, Good Clinical Practice, endpoints, and biostatistics basics.
Medical Device Reporting, complaint handling, post-market clinical follow-up, and recalls.
Socket design, prosthetic components, orthotic bracing principles, and gait-cycle biomechanics.
Pacemakers, ICDs, heart valves, and stents — design and physiological interface considerations.
Neurostimulation, the electrode-tissue interface, deep brain stimulation, and cochlear implants.
Pharmacokinetics basics, infusion pumps, and controlled/transdermal/implantable release.
Medical equipment management programs, preventive maintenance, electrical safety testing, and CBET.
Applied parts classification, leakage current limits, means of protection, and essential performance.
Attack surface of connected/implantable devices, FDA premarket cybersecurity guidance, and secure design.
A complete ISO 14971 risk file for a hypothetical infusion pump — hazard analysis, controls, and residual risk.
A predicate comparison for a hypothetical Class II wound care device — equivalence table and testing gap analysis.
A worked battery-life and chemistry-selection calculation for a hypothetical implantable neurostimulator.
An ECG instrumentation amplifier design — gain/CMRR calculation, filter design, and right-leg-drive rationale.
An EtO sterilization validation protocol for a surgical instrument kit — bioburden plan and acceptance criteria.