Model-based assurance and certification aims to facilitate the underlying activities by means of models, which can facilitate the understanding of safety standards, the determination of the evidence to collect, and compliance assessment, among other tasks. This method has been improved to tailor it to further, specific assurance & certification needs.

Tailoring it to the healthcare domain. The tailoring process implies the specification of models for representation of healthcare devices and of the activities related to the development of these devices. Consequently, it would be possible to define specific device and process models by using the conceptual constructs defined, which can be automatically analysed to obtain compliance levels to reference quality models or certification standards.

Application to product-based standards. The extension of Model-based assurance and certification to specific product-based standards involves the translation of the standards involved to appropriate model-based representations that will be used as input artifacts for the V&V process. Reusable safety certification models can be obtained according to the different application domains.

Provision of further support to cross-standard compliance analysis. A relevant element to support the V&V processes related to different standards or application domains is the analysis of equivalencies that exist among different certification models. By providing identification facilities for these equivalences, it would be possible to reuse already performed certifications to determine the degree of compliance in relation to new standards to be adopted. As a result, the effort of certifying or re-certifying a system is reduced.

Some improvements have already been referred to in a publication [TMAC1].