IN ONE SIMPLE SENTENCE
Non-clinical tests and evidence used to assess device safety and performance before broad human use.
What is this service?
Before broad human use, the device should be assessed as far as possible for basic technical safety and performance. The exact tests depend on the device.
GOAL
Reduce risk before human studies and show that the device works safely and correctly under defined conditions.
What can MICT do here?
MICT can plan or coordinate testing, consolidate results from qualified laboratories and review whether the evidence supports the product claims.
TYPICAL INPUTS
What we usually need to start
- Device sample or technical specifications
- Initial risk analysis
- Performance claims
- Applicable standards
- Previous design and test reports
TYPICAL OUTPUTS
What this stage can deliver
- Test plan
- Performance-test report or summary
- Technical evidence matrix
- Identification of missing or redundant tests
- Inputs to risk management and clinical evaluation
Important terms in plain language
Preclinical
Activities performed before a human clinical investigation.
Performance Testing
Testing whether the device performs its intended function with suitable accuracy and consistency.
Biocompatibility
Assessment of whether patient-contacting materials are biologically acceptable.
Bench Test
Laboratory testing of the device or components without clinical use on patients.
Validation
Documented evidence that a method, system or product is suitable for its intended purpose.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
For a blood-pressure monitor, testing can include measurement accuracy, repeatability, cuff performance, device durability and environmental conditions.