Learn to develop real medical devices from concept through post-market surveillance โ 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.
25 modules in 7 phases, with worked examples, interactive tools, labs and a quiz in every one, and a certificate of completion.
Build a battery-energy estimate and document test assumptions.
The design targets full use of the ADC's 3.3V input range without clipping at the largest expected ECG amplitude. Using the worst-case 4 mV peak differential input and reserving headroom so the amplified signal does not saturate the amplifier's output stage at the rail, the target peak output is set to 3.0V (leaving 300 mV, or about 9%, of headroom below the 3.3V rail). Solving for the required gain: G =โฆ
Selected training excerpt, not a complete design or a project submission. The full project includes its assumptions, methods and checks.
Build your own phase-by-phase workbook, record the evidence behind your decisions and download your work.
Estimate ideal runtime from usable battery energy and a constant electrical load. Then identify one real-world allowance.
Ideal runtime = usable energy รท load power
Ideal energy balance only; no chemistry, discharge-rate, safety or regulatory sizing model. This free exercise does not mark a paid module complete.
Related full-program tool: Device Battery Life Calculator โChoose a phase to explore its lessons and project work.
Start with the free lesson โCovers Device Classification & Regulatory Strategy, Quality Management Systems and Risk Management.
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 โ hazard analysis, risk control hierarchy, residual risk, and benefit-risk analysis.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
Covers Biomaterials, Biomechanics, Biosignal Processing, Medical Imaging Fundamentals and Sterilization & Packaging.
Material classes โ metals, polymers, ceramics โ 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.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
Covers Human Factors & Usability Engineering, Software as a Medical Device (SaMD), Clinical Trials & Evidence Generation and Post-Market Surveillance.
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.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
Covers Prosthetics & Orthotics Engineering, Cardiac Devices, Neural Devices and Drug Delivery Systems.
Socket design, prosthetic components, orthotic bracing principles, and gait-cycle biomechanics.
Pacemakers, ICDs, heart valves, and stents โ 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.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
Covers Hospital & Clinical Engineering Operations, Electrical Safety (IEC 60601) and Cybersecurity for Connected Medical Devices.
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.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
You apply what you have learned to 5 complete designs, starting with Device Risk File.
A complete ISO 14971 risk file for a hypothetical infusion pump โ hazard analysis, controls, and residual risk.
A predicate comparison for a hypothetical Class II wound care device โ equivalence table and testing gap analysis.
A worked battery-life and chemistry-selection calculation for a hypothetical implantable neurostimulator.
An ECG instrumentation amplifier design โ gain/CMRR calculation, filter design, and right-leg-drive rationale.
An EtO sterilization validation protocol for a surgical instrument kit โ bioburden plan and acceptance criteria.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
Covers Sustainability, Reprocessing & Capstone.
Single-use device reprocessing, environmental sustainability in device design, professional practice, and your certificate of completion.
Project checkpoint: Record the assumptions, calculations and evidence behind this phaseโs outcome in your project workbook.
By the end: Covers Device Classification & Regulatory Strategy, Quality Management Systems and Risk Management.
Device engineering workbook: Build a battery-energy estimate and document test assumptions. Keep a result and a verification note for each phase.
Your All-Access includes the project workbook, lesson notes, self-review checklists and portfolio downloads. Try the free lesson above to see a worked example.
Your name
Applied Biomedical Engineering Professional ProgramEngineersUniverse ยท self-paced learning
Finish all required module quizzes to unlock your certificate of completion. Modules with a score requirement must meet that requirement. Your project portfolio and skills summary are separate downloads for your own learning record.
A certificate of completion is not a professional license or accreditation.