The International Medical Device Regulation Forum (IMDRF) has recently published two documents that aim to help medtech manufacturers in ensuring their products are cybersecure. In its most recent guidance, the organization outlines how companies can use a concept known as the software bill of materials (SBOM) concept to prevent and address cybersecurity risks.
The 29-page document,
What Are SBOMs?
A SBOM, which stands for software bill of material, is a cybersecurity concept in which product manufacturers declare an inventory of components used to build a software artefact such as a software application.
For medtech companies, patient safety can be improved by using SBOMs in addition to complying with other standards, regulations and guidance issued from national and international organizations
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