Our Strategy

ValidationCPR intersects regulations, standards, and business agility

The key to our strategic approach is to use a battery of test-type attacks of the software and apply these attacks at multiple levels, using safety risk to appropriately scale. Our goal is to assist our clients at identifying bugs as EARLY, as EFFECTIVELY, and as EFFICIENTLY as possible, in a sustainable manner.

We recommend and guide our client on how to test software at multiple levels as found in the FDA General Principles of Software Validation.

Unit Verification

Our staff can provide multiple types of unit verification ranging from code inspection and review, static analysis methods (including setup of purchased tools, and development or review of dynamic unit test assets. Clearly, dynamic unit tests have the highest value when the software is being developed, so early involvement is key.

Module and Integration Testing

As the software is being integrated during development, our staff can help with verification strategy and planning to ensure that critical software modules have suitable test assests to allow various test types not possible at the system level. These module test assets can become the foundation of your regression testing strategy. Our staff has experience with both embedded systems and Software as a Medical Device (SaMD) systems - and with various automation tools for these types of tests. We can even construct custom fixtures and "hardware in the loop" designs to allow deep and thorough testing for the most safety critical systems.

System Testing

For many lower risk devices, the bulk of your testing will likely be system level. Our staff will help guide in strategies for automation where it makes sense and key coverage expected by regulators and auditors.

Contact Us

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T: (813) 766-0563