Hardware testing
Electrical safety & essential performance
For medical electrical equipment, check protection of patients and operators under normal and applicable single-fault conditions.
- Leakage currents, insulation, dielectric strength and protective earth where applicable
- Accessible temperatures, power interruptions and battery operation
- Continued essential performance or the specified safe response during faults
Electromagnetic compatibility (EMC)
Check emissions and immunity for the intended use environment and device configuration.
- Conducted and radiated emissions
- Electrostatic discharge, RF immunity and applicable power-line disturbances
- Monitor essential performance, alarms and recovery during and after exposure
Mechanical, environmental & lifetime tests
Evaluate conditions expected in transport, storage, routine use and servicing.
- Drop, vibration, enclosure strength and connector endurance as applicable
- Temperature, humidity and fluid ingress appropriate to the use environment
- Battery ageing, repeated operating cycles and wear of moving parts
Measurement & therapeutic performance
Verify device-specific accuracy and outputs using calibrated reference equipment.
- Sensor accuracy, repeatability, drift and calibration across specified ranges
- For applicable devices: delivery rate, pressure, energy output or measurement response time
- Disconnected sensors, blocked flow paths, actuator faults and protective limits
For medical electrical equipment, relevant frameworks include IEC 60601-1 — basic safety and essential performance and IEC 60601-1-2 — EMC. Device-specific particular standards and other applicable standards must also be considered; IEC 60601 does not cover every medical device category.
Software testing
Code analysis & unit tests
Verify individual components and identify defects before full-system integration.
- Review requirements and code; apply static analysis and coding rules
- Test normal, boundary and invalid inputs, calculations and state transitions
- Check error handling and coverage appropriate to the software safety classification
Integration & system verification
Check software behavior on the intended hardware and supported operating platforms.
- Interfaces between sensors, drivers, application logic and user interface
- Timing, memory, processor load, concurrency and long-duration operation
- Requirements-based regression tests after software or configuration changes
Data integrity & interoperability
Verify that information remains correct as it is stored, displayed and exchanged.
- Patient identification, units, timestamps and calculation consistency
- Backup, restore and recovery from interrupted writes or network loss
- Where supported: DICOM, HL7 or FHIR interfaces; malformed or incomplete messages
Updates & cybersecurity
Select security tests from the threat model and cybersecurity requirements.
- Authentication, authorization, secure communications and protection of sensitive data
- Authorized vulnerability testing, interface fuzzing and dependency assessment
- Update authenticity, integrity and recovery from interrupted installation
IEC 62304 addresses medical device software lifecycle processes. Security work should cover the product lifecycle; the FDA cybersecurity resources provide additional guidance for the US market.
Complete-device validation
Fault handling & alarms
Check the response to hazards identified by the device risk analysis.
- Simulate sensor failures, depleted batteries, lost communication and invalid inputs
- Verify alarm conditions, priority, visibility, audibility and acknowledgement where relevant
- Confirm protective actions and recovery do not create unacceptable additional risks
Usability & human factors
Evaluate safe use by representative intended users in representative use environments.
- Formative evaluations during design to identify use difficulties
- Validate safety-related tasks, controls, displays, labels and instructions
- Assess foreseeable use errors and effectiveness of related risk controls
Biological safety & reprocessing
Apply these assessments where materials contact the body or the device is cleaned, disinfected or sterilized.
- Base biological evaluation on materials, contact type and contact duration
- Use existing evidence and identify testing needed to address gaps
- Validate applicable cleaning, disinfection, sterilization, packaging integrity and shelf life
Intended-use performance
Validate that the finished device meets user needs and its intended purpose.
- Use representative configurations, accessories and operating scenarios
- For applicable algorithms, evaluate performance on representative independent data
- Plan clinical evaluation or IVD performance evaluation as applicable; technical tests alone do not establish clinical benefit
Risk controls and their verification should follow a risk-management process such as ISO 14971. For biological evaluation, see the FDA biocompatibility resources. Testing should address identified evidence gaps rather than applying every biological test to every device.
For usability planning and validation, see FDA human factors and usability engineering guidance.
A test programme matched to the device
- Define scope and risksIdentify device type, intended use, markets, essential performance and safety-related functions.
- Plan verificationDefine test methods, acceptance criteria, samples, configurations and traceability to requirements and risk controls.
- Test and validateCombine component tests, simulation, hardware/software integration, complete-system tests and intended-use validation.
- Review and maintain evidenceRecord results, deviations and unresolved anomalies. Assess changes and repeat affected tests throughout the lifecycle.
Reports should identify hardware and software versions, test equipment and calibration, test conditions, objective results, requirement coverage and remaining limitations. Production acceptance tests complement design verification and validation.
Software verification checks specified requirements; validation addresses intended use and user needs. See the FDA software guidance navigator for US guidance.
Standards and market requirements
The required programme depends on device classification and target market. For Europe, distinguish medical devices under the MDR from in vitro diagnostic devices under the IVDR. Confirm applicable standard editions and their regulatory status before testing. Standalone medical software needs an appropriate software and system validation plan; electrical bench tests do not automatically apply to software alone.
Testing supports the technical evidence for conformity assessment. This overview is not a universal checklist, certification or market authorization.
European references: MDR and IVDR overview and harmonised standards for medical devices.
Contact MPS about your medical device testing requirements