A Critical Part of Medical Device Development
Verification and Validation Testing
V&V Testing
Verification and validation testing is a required part of medical device development; we develop our test criteria using design inputs and risk assessments.
V&V testing is device-specific. Some of the tests we commonly run are:
- System Performance
- Environmental Performance
- Formative Usability
- Electrical Safety, IEC 60601-1
- EMC Testing, IEC 60601-1-2
- Electrical Performance
- Software and Firmware
- Biocompatibility
- Cytotoxicity
- Labeling
- Packaging Integrity and Shipping
- Light Safety
- Physical Characteristics
- Sterilization Validation
- Cleaning Validation
- Summative Usability
We perform all of this testing in-house except for testing that requires specific lab qualifications such as IEC 60601 testing, biocompatibility, cytotoxicity, sterilization, and shipping.
Test and Assembly Fixtures
Testing is a critical and required part of medical device development and manufacturing. We have an in-house team that specializes in creating and building test, assembly, and calibration fixtures. We use these fixtures throughout the design process, from benchtop testing to structured V&V testing and into manufacturing.
Test and Assembly Fixtures
