| 1 |
Define the intended use |
Training purpose and user profile |
Confirm whether the mannequin is intended for basic skills practice, advanced clinical simulation, assessment, research, or device testing. Identify expected users, such as students, nurses, physicians, or emergency responders. |
A documented intended-use statement, defined user groups, training scenarios, operating environment, and clearly stated limitations. Determine whether medical-device regulations apply to the specific intended use. |
The mannequin may not support the required procedure, user group, or regulatory pathway. |
| 2 |
Check ISO 13485 quality-system evidence |
Manufacturing and quality management |
Ask whether the manufacturer operates a quality management system certified to ISO 13485:2016, where applicable to the product and market. Verify the scope, certificate status, and certification body. |
A current certificate showing ISO 13485:2016, an applicable scope covering design and/or manufacture, certificate validity dates, and an identifiable accredited certification body. ISO 13485 certification alone does not prove product performance or regulatory approval. |
Weak control of design changes, suppliers, records, complaints, or corrective actions. |
| 3 |
Review usability-engineering controls |
IEC 62366-1 design and use safety |
For products within the applicable medical-device scope, determine whether the design process considers user characteristics, use environments, use errors, critical tasks, and reasonably foreseeable misuse. |
Request relevant usability-engineering records, including a use specification, user-interface evaluation, use-related risk analysis, formative or summative evaluation results, and user instructions. IEC 62366-1 is a process standard; it is not a product certification label. |
Incorrect setup, confusing controls, or preventable use errors during training or assessment. |
| 4 |
Match clinical functions to the curriculum |
Anatomy, procedures, and measurable responses |
Compare the mannequin's functions with the required procedures, including airway management, cardiopulmonary resuscitation, vascular access, wound care, childbirth, patient assessment, or other specified skills. |
A traceability matrix linking every required learning objective to a demonstrated mannequin function, such as anatomical landmarks, physiological responses, feedback, and scenario controls. |
Learners practice incomplete or unrealistic steps and cannot be assessed consistently. |
| 5 |
Verify materials and infection-control requirements |
Cleaning, durability, and compatibility |
Confirm skin and airway materials, fluid pathways, replaceable parts, cleaning agents, disinfectant compatibility, drying requirements, and restrictions on invasive or sharps procedures. |
A manufacturer cleaning and disinfection procedure, validated or documented compatibility information, defined replacement intervals, and a list of prohibited chemicals or procedures. Do not assume the mannequin is suitable for clinical patient decontamination protocols. |
Material cracking, discoloration, microbial contamination, inaccurate performance, or premature component failure. |
| 6 |
Assess technical performance and integration |
Reliability, software, and interoperability |
Evaluate sensor accuracy, feedback latency, power requirements, connectivity, software updates, data export, cybersecurity controls, and compatibility with the institution's audiovisual or learning-management systems. |
Documented operating specifications, acceptance-test results, backup and recovery procedures, access-control information, software-version records, and a live demonstration using the planned training workflow. |
Interrupted sessions, unreliable assessment data, integration delays, or loss of training records. |
| 7 |
Confirm lifecycle support and procurement controls |
Serviceability, documentation, and total cost |
Review warranty terms, preventive maintenance, spare-part availability, calibration or verification needs, technical support, staff training, delivery requirements, and end-of-life arrangements. |
A written service-level agreement, parts and support availability period, user and maintenance manuals, installation qualification checklist, acceptance-test protocol, and a total-cost estimate covering consumables, repairs, software, and training. |
High downtime, unexpected ownership costs, unavailable parts, or inability to maintain training consistency. |