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The Importance of an Incident Response Plan

Medical device manufacturers must follow various regulations for their fielded devices, generally referred to as postmarket requirements, which include tracking and reporting malfunctions and injuries. Most have formal procedures and processes in place to satisfy these requirements. However, security incidents impact medical device manufacturers, and their customers, in ways that go beyond the requirements satisfied by existing procedures. Effective response to security incidents requires …

Developing an Incident Response Plan for Medical Device Manufacturers

As we explored in the article titled “The Importance of an Incident Response Plan”, one of the most cost- effective mitigation tools against cybersecurity breaches is the incident response (IR) plan. In addition to the IR plan, having a formal IR team periodically testing the developed IR plan was shown to boost this effectiveness, providing medical device manufacturers with solid footing for an effective response to an incident. According to the National Institute of Standards and Technol…