- Valid clinical association or scientific validity: degree of association between the SaMD’s output (concept, conclusion, measurements) and targeted clinical condition or healthcare situation
- Analytical/technical validation: ability of the SaMD to process input data correctly and reliably and accurately, reliably, and precisely generate the technical output. This is usually confirmed during the verification and validation phase of software development by the manufacturer using a QMS.
- Clinical validation: proof that the SaMD’s output data achieves the product’s intended purpose in terms of clinical care which maybe diagnosis, treatment, prediction of risk or response. Clinical validity is determined and evaluated by the manufacturer both during the pre-market and post-market phases.
Evidence generation is an important component of all clinical evaluation activities and therefore it is important to choose a partner that can help you along the way. Our team at ProRelix Research collaborates with you to understand your SaMD needs and provides the following services:
- Collection and collation of existing evidence from literature searches, original clinical research, and professional society guidelines, clinical guidelines in peer-reviewed journals
- Collection of patient data or extraction from databases for analytical validation
- Design of clinical plans and development of clinical study reports
- Continuous monitoring and collection of real-world evidence (RWE)
- Data collection from post-marketing studies
- Development of quality documents such as Standard Operating Procedures (SOPs)
