As outlined in the FDA premarket cybersecurity guidance, medical device manufacturers should produce a Secure Product Development Framework, or SPDF. An SPDF outlines processes for reducing the number and severity of vulnerabilities, through discovery to monitoring. Manufacturers face a variety of pain points when existing processes aren’t meeting FDA standards, which can lead to hold letters, and delay a device’s market approval. In this webinar, Om Mahida and Seth Carnody will help regulatory specialists, product security engineers, and R&D leaders understand the types of vulnerabilities they may encounter and what to consider when developing a Secure Product Development Framework that meets regulatory requirements.
- Develop an understanding of what device manufacturers should focus on when it comes to vulnerability lifecycle management
- Learn about different types of vulnerabilities and methods for assessment and mitigation
- Develop a path forward for vulnerability management and quality system processes
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