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.
Attendees will:
- 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
Our team of FDA analysts and cybersecurity experts provide robust and actionable cybersecurity roadmaps to ensure you meet FDA requirements. Get the Medcrypt advantage today!
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