Working Sets: Working with existing Working Sets
Abstract
On March 29th, 2023, FDA’s new product cybersecurity enforcement begins. December’s Omnibus Bill requires Medical Device OEMs to submit a Software Bill of Material (SBOM) and to use SBOMs to coordinate Post-Market product cybersecurity efforts. This legislation applies to all products (including legacy) with software defined components and is meant to replace the FDA’s proposed medical device cybersecurity requirements (taken from the PATCH Act).
- What the new Omnibus Law/FDA requirements mean for Medical Device Manufacturers
- How functional safety relates to product and patient security
- Why aligning product security to your product’s lifecycle and digital thread is the long-term formula to success