Compilation of the complete Performance Evaluation Report (PER)
Surveillance of public vigilance and complaint databases
Regular updates
Write Summary of Safety and Performance (SSP)
Clinical Performance
Clinical performance studies
Research on scientific peer-reviewed literature
Analyse published experience gained by routine diagnostic testing
Write clinical performance report
Analytical Performance
Perform analytical performance studies, providing evidence on
reliable, accurate and consistent measurement
and/or detection of analyte,
considering all different types and sampling conditions
Use supportive evidence from routine diagnostic testing
Compile analytical performance report
Scientific Validity
Identify available data and literature relevant to devices measuring the same analyte or marker
Appraise all relevant data by assessing their suitability
Define search strategy being able to identify relevant favourable and unfavourable data
Apply other data retrieval methods
Prepare traceable search protocol
Find remaining gaps systematically
Generating any new evidence to resolve open issues by means of clinical performance studies, analytical performance studies or PMPF studies
Compile appropriate scientific validity report
Identify Data Sources
Appraised literature data from multiple databases
Peer-reviewed data
Published clinical data, e.g. Summary of Safety and Performance (SSP), Registries and databases from authorities
Relevant information on the scientific validity of devices measuring the same
analyte or marker
Proof of concept studies
Relevant consensus expert opinions/positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device
Study Services
Full service for clinical performance studies, analytical performance studies, PMPF studies and other studies.