medtech cro services - quality assurance

Draft of Principles and Practices for Software Bill of Material for Medical Device Cybersecurity

August 23, 2022

Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from different manufacturers.

Compounding the issue is the limited traceability of many common components in electronical #medicaldevices.

When it comes to dealing with this problem, the US National Telecommunications and Information Administration (NTIA) organized a multi-sector effort of several stakeholders in 2018. In the end, NTIA described the SBOM as a list of one or more components, together with any related metadata, as a “bill of materials.” With the help of SBOM, the whole product life cycle (TPLC) may be streamlined.

#IMDRF document provides:

  • Recommendations for medical device manufacturers in SBOM generation, management, and distribution
  • Recommendations to healthcare providers on the ingestion and management of an SBOM
  • Showcase SBOM use cases for #riskmanagement , vulnerability management, and incident response from the perspective of medical device manufacturers and healthcare providers.

There has been increased uptake and application of ML-enabled techniques in medical devices. We refer to these medical devices as MLMD. Medical devices and software as a medical device (SaaS) are the most common delivery methods for AI-based solutions. New and essential insights may be gleaned from the large amounts of data that are created during all stages of the healthcare process using MLMD. One of the main benefits of MLMD lay in the ability for continued learning and iteration when new data becomes available, including from real-world use and experience to improve its performance.

Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.

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