The selected design must be demonstrated to meet the established product requirements, including performance. Depending on the product being a software or a hardware product, or a combination, Nordic Proof can facilitate services which include:
Clinical evaluation of prototypes
System Level testing
Demonstrate value based outcome
Nordic Proof can provide access to experts and test facilites where testing can be performed on your prototype(s) to determine whether you designed the medical device right.
In case your medical device is a software we have the expertice available which can perform design verification to ensure that the software is built correctly based on the software requirements (i.e., design inputs), with regard to each task the software must perform (i.e., unit testing), during communication between software modules (i.e., integration testing) and within the overall system architecture (i.e., system level testing)
Risk analysis for evaluating potential problems which could be encountered in connection with using a medical device can be part of the testing regime which you can get performed and documented through Nordic Proof.
Nordic Proof can make available arenas for demonstrating a value based outcome
User Need Validation
Validation is the activities that confirm that the product meets customer requirements consistently (the user needs) through simulated or actual use conditions. Nordic Proof partners has the competence and facilities to be your clinical partner during validation.
Clinical trial/Clinical investigation
Confirm intended medical benefit
Effectiveness / health economy
Value based outcome
Ensure the HW/SW design execute on the design concept
For testing of medical devices involving people there are given standards, directives, guidelines and procedures you have to follow.
Once your design transfer is complete and you have available units produced by manufacturing you can utilize Nordic Proof partners to perform various testing to perform your clinical evaluation and clinical investigation. Including hazard analysis.
For software based medical devices the validation shall confirm that the user needs is addressed by the software.
Nordic Proof can benchmark your product in terms of value based outcome