This whitepaper, written by medical device cybersecurity and regulatory experts from Medcrypt and the Johner Institut, serves as an introduction to the overarching cybersecurity responsibilities medical device manufacturers face across the lifecycle of their products. It covers key regulatory requirements and offers a high-level overview of best practices, illustrating the need for cybersecurity integration from the earliest design stages to ongoing market surveillance. Future publications and webinars will delve deeper into each aspect of this lifecycle, equipping manufacturers with the knowledge to ensure compliance and, ultimately, patient safety in an increasingly digital healthcare environment.
Here’s what you’ll take away
Understanding Market Approval Across Regulatory Frameworks:
Gain a clear understanding of how global regulatory bodies, including the FDA and EU, evaluate medical devices for secure communication and data exchange. Explore the nuances of compliance within multiple jurisdictions.
Navigating FDA vs. EU Regulatory Pathways:
Learn the critical differences and similarities between FDA and EU requirements for secure communication, including data integrity and privacy. Understand the challenges in reconciling these frameworks for global market entry.
Key Security Standards and Frameworks:
Familiarize yourself with essential medical device security requirements such as US FDA and EU MDR/IVDR
Common Pitfalls in Secure Communication Compliance:
Discover common challenges medical device manufacturers face when attempting to meet global security standards, and how to avoid the most frequent mistakes, from missing cybersecurity lifecycle activities to inadequate implementation of cryptographic protocols and insecure key management.
Strategies for Global Regulatory Success:
Learn best practices for implementing secure communication protocols that align with multi-regulatory requirements. Explore strategies that can streamline your path to market approval while maintaining the highest level of device security.
The Future of Medical Device Security Compliance:
Gain insights into upcoming trends in regulatory expectations and how to stay ahead of evolving requirements for secure communication, ensuring long-term compliance and device security in a global market.
