HKIE Professional Assessment - Biomedical Discipline study plan

Derive and apply the stress-strain relationships for cortical bone and a typical titanium alloy, then compute the axial stiffness of a simplified femoral stem under a 2 kN load

Explain the physiology of the cardiac cycle, glomerular filtration and pulmonary gas exchange in engineering terms, linking each to a measurable quantity such as pressure, flow or clearance

Classify biomaterials by degradation behaviour and contrast the host response to a permanent metal implant versus a resorbable polymer

Solve three worked biomechanics problems on joint reaction forces and beam bending of long bones without referring to notes

Design a signal chain for an ECG front end, selecting electrode type, amplifier gain, filter cut-offs and sampling rate with stated justification

Calculate the leakage current and patient auxiliary current limits applicable to a Type CF applied part and identify which IEC 60601-1 clauses govern them

Compare optical, piezoelectric and capacitive sensing principles for SpO2, blood pressure and respiration respectively, stating one failure mode for each

Draw a block diagram of a closed-loop infusion pump safety architecture including independent over-infusion protection

Build a preventive maintenance schedule for a ventilator and an electrosurgical unit, specifying intervals, tests and acceptance criteria

Perform a full ISO 14971 risk assessment on one device, producing a hazard list, severity and probability scoring, and at least three risk control measures traced to verification evidence

Map the clauses of ISO 13485 to the lifecycle stages of a device from design input to post-market surveillance

Explain how the Hong Kong MDACS listing process differs from the mainland NMPA and EU MDR routes, and state which documents each requires

Calibrate a simulated pressure transducer against a reference, record readings and compute measurement uncertainty

Interpret the IEC 60601-1 third edition collateral and particular standards structure and identify which particular standard applies to three named device types

Analyse two published medical device incident reports, identifying the root cause, the violated control and the corrective action taken

Apply the four principles of biomedical ethics to a case where a clinician requests off-label use of a device, and justify a recommendation

Draft a health technology assessment recommendation for a new imaging modality using clinical, technical and economic criteria

Explain the professional obligations of an engineer signing off a medical device acceptance test in Hong Kong, including record retention and duty to report

Implement a digital filter in code to remove baseline wander and 50 Hz interference from a sampled ECG record, and report the signal-to-noise improvement

Compute and interpret the frequency spectrum of a biomedical signal, distinguishing physiological content from artefact

Explain the reconstruction pipeline of CT and MRI in engineering terms, including projection, back-projection, k-space and image quality metrics

Assess a health informatics scenario for data privacy obligations under the Personal Data (Privacy) Ordinance and propose an anonymisation approach

Evaluate the performance of a diagnostic classifier using sensitivity, specificity, ROC curve and positive predictive value at a stated prevalence

Compare scaffold material options for a cartilage repair application on mechanical, degradation and biocompatibility criteria

Explain the regulatory pathway and evidence expectations for a combined cell-scaffold product, and identify where device and biological requirements diverge

Critically appraise one emerging technology such as surgical robotics or AI-based diagnosis, stating its maturity, evidence base and adoption barriers

Produce a personal continuing professional development plan aligned to the competencies the assessment tests, with specific activities and evidence

Produce a project schedule for installing a new imaging suite, including dependencies, critical path, procurement lead times and commissioning milestones

Identify the facility interfaces for that installation, covering electrical supply, cooling, shielding, structural loading and infection control

Draft a stakeholder communication plan distinguishing clinical users, estates, infection control and finance

Quantify the cost of downtime for a critical device and justify a redundancy or service contract decision

Sit a timed mock examination under exam conditions and mark it strictly against model answers

Re-derive the ten formulas most frequently needed across the domains from memory

Identify the three weakest domains from the mock result and close each gap with targeted practice

Rehearse concise verbal explanations of risk management, device lifecycle and professional ethics suitable for a viva