Technical Validation. An approval issued by the VA following a review of technical documents which is more in depth than a review for a streamlined validation. - This applies to all design approvals not eligible for Acceptance or Streamlined Validation.
Technical Validation. Before using the novel measurement in pauents, a robust assessment of the usability, reli- ability and reproducibility of the technology and flow of data should be performed. Minimal technological standards The reliability and consistency of devices should be assessed in the form of inter- and intra-device variability. The flow of data should be automated, requiring as liчle manual input as possible in order to reduce data (entry) errors. The flow should be consistent and allow for the subjects’ privacy by design, for example via encrypted transmission of data23. Furthermore, the data flow must be part of the validauon and comply with the necessary Fda regulauons regarding audit trails and the storage and processing of source data11. In the case of technological gold standards that can be used as a reference, a head-to-head comparison should be conducted in a standardized seчing to determine the bias and limits of agreement, specificity and sensiuvity, depending on the type of measurement. Furthermore, an analysis should be conducted with non-pauent test subjects to ensure that a novel measurement truly captures the behavior, symptom, or acuvity it aчempts to quanufy in various real-life situauons. For example, a smartphone accelerometer is capable of counung steps taken per day, but some may leave their phones on a desk or in a locker, bag or jacket when going for a walk, which leads to low accelerometer counts with liчle informauon of the underlying reason. While it is not possible to simulate all situa- uons that might occur in daily life, a supervised test of limited durauon may result in the detecuon of easily addressable confounders. In this case, the exact clinical relevance will not yet be determined, and the test subject merely funcuons as a free-living data gener- ator in a closely observed seчing. In this phase of validauon, it is also advised to consider the amount of training and instrucuon that will be necessary to ensure measurements are conducted correctly by pauents. Not all these steps are feasible in all cases. For example, when there is no obvious tech- nical gold standard or when the measurement is a completely new concept, a head-to- head comparison is impossible. In this case, technical validauon is necessarily more limited and clinical validauon gains a larger role. Handling of discordance Technological validauon of novel measurements is vital for the validauon process, and if there is a near perfect agreement with an unchallenged t...
Technical Validation. The overall architecture is validated trough the validation of the workflows and the integration of its components. Each technical aspect is carefully checked and validated on a binary scale (a technical criteria is fulfilled or not). Below is the list of technical criteria to be checked, together with their respective information regarding their validation. Some of the criteria have been partially extracted from the document [WP8, D8-1](User Requirements)/2.3/2.4.
Technical Validation. Phase 4 OBJECTIVE COMPLIANCE VERIFICATION First Compliance determination activities Issuance of VA Certificate → The VA shall issue its validated design certificate (e.g. TC for an aircraft, aircraft engine or propeller) when: Beginning the CA has issued its own initial certificate; the applicant has demonstrated and declared compliance to the VA’s certification basis; the CA has issued a statement of compliance to the VA’s certification basis; all issues raised during the validation process conducted by the VA have been resolved; and End Administrative fees have been paid by the applicant in accordance with the applicable VA’s Fees and Charges regulation. CONSIDERATIONS: DATA PACKAGE, APPLICATION TIMELINE Your safety is our mission. An Agency of the European Union DATA PACKAGE For projects subject to a validation process, an application to the VA through the CA is necessary. The application package consists of:
