VerIfication and Validation of Ai-enabLeD sYstems

Vivaldy logo

a Penta project

Penta-Eureka Eureka Network

Strategic Challenges - Areas addressed

Digital industry

  • Develop digital twins, simulation models for the evaluation of industrial assets at all factory levels and over system or product life-cycles

Systems and components: architecture, design and integration:

  • Managing critical, autonomous, cooperating, evolvable systems
  • Providing effective module integration for highly demanding environments
  • Verification and Validation (V&V) and Test for critical systems: Methods and Tools
  • Complexity reduction for V&V and Test

Safety, security and reliability

  • Ensuring reliability and functional safety
  • Security and safety for hardware and software throughout the whole lifecycle


Products become increasingly intelligent, connected and linked with the physical world. Cyber-physical systems (CPS) cause disruptive changes to products, services, business models, and markets. Key aspects of advanced industrial CPS are (i) regular component upgrades (AI, SW, modules and HW) after initial product release and (ii) application of AI techniques to add extra value. A consequence is that the initial verification and validation for CPSs rapidly loses its evidential value throughout the product lifecycle. This holds in particular for professional healthcare systems where patient-safety is paramount. Companies like Philips and Barco face the challenge for cost-efficient re-verification, re-validation, and certification of incremental CPS upgrades ensuring its intended use while being competitive with the development speed of American and Asian companies.

An incremental upgrade release-cycle for (AI enhanced) healthcare CPS promises rapid incremental dissemination of innovations, a better response to fast changing public health challenges, augmenting patient engagement, and improving the quality of care of patients. However, an agile regulatory paradigm to accommodate the faster rate of new product introductions – while ensuring that existing standards of safety and effectiveness are met or exceeded – is still lacking.

This challenge is taken up by the Vivaldy consortium by realizing efficient re-verification & re-validation and effective regulatory approval guidelines for the incremental upgrade of class II, AI-enhanced CPSs in the professional healthcare domain. The Vivaldy KPI’s are to increase the frequency for (i) major system upgrades from 3 years to once a year and (ii) for module and/or AI upgrades from once a year to once every 6 months.

Vivaldy will address re-verification and re-validation by analysing field obtained user/usage data, change-based impact analysis, and integrated virtual and physical testing. Results will be proven on 4 industrial use cases each targeting a specific type of upgrade ranging from hardware, component, to AI applications. Via regular discussions with healthcare certification bodies and partners active in other safety-critical industry domains, Vivaldy will disseminate its results & guidelines to a wider audience, reflect on their experiences, and contribute to standards for certification.

Vivaldy Project Partners


Philips Healthcare

OEM Professional healthcare
system provider


OEM Professional healthcare
system provider


SME AI brain imaging
solutions provider


SME Engineering tools for
modelling and verification


SME Engineering tools for
modelling and verification

TU Delft

Academic partner Multicore heterogeneous
hardware systems


Research group Systems design &


Research institute AI in
healthcare domain


Publications will be listed here, once they are published.

Prespective has published a case study of their work with Philips IGT in the Vivaldy project. Follow this link to go to the case study

A tool to analyse AI performance and safety for subpopulations has been published during SPIE Medical Imaging 2023:
Follow this link to see the paper on Paper 12465-70
The source code of the tool is available on



The Vivaldy project resulted in 4 demonstrators; one per use case.
Click the following links for these demonstrators:



About Vivaldy

  Vivaldy Penta project profile  

 Size:   Effort: 65 PY   Costs: 10.0 M€  
 Time frame:   Start: 2020-02-01   End: 2023-01-31 (36 months)  
 Coordinator:   Belgium   Barco N.V.  


PENTA is a EUREKA cluster whose purpose is to catalyse research, development and innovation in areas of micro and nanoelectronics enabled systems and applications. Guided by the Electronic Components & Systems (ECS) Strategic Research Agenda (SRA) key application areas and essential capabilities, the PENTA programme enables the development of electronic solutions to help drive the digital economy through the formation of collaborative ecosystems along the ECS value chain. This creates the opportunity for rapid competitive exploitation and a strong impact on European societal challenges. PENTA supports SMEs, large corporations, research organisations and universities to work together in project consortia by facilitating access to funding, fostering collaborative work and creating consortia in areas of mutual industrial and National interest.

PENTA is operated by AENEAS. More on PENTA:
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