Blog
In today’s connected healthcare landscape, cybersecurity is not just a technical requirement, it’s a strategic investment. For medical device manufacturers, early planning can significantly reduce cybersecurity costs while improving compliance, product safety, and time to market. In this blog, we explore how proactive cybersecurity planning can help companies avoid costly mistakes and meet evolving regulatory expectations in both the U.S. and EU.
1. Start Cybersecurity at the Concept Phase
Waiting until the end of development to address cybersecurity can lead to expensive redesigns and regulatory delays. By integrating cybersecurity from the concept phase, manufacturers can identify risks early and design secure systems from the ground up.
2. Build Threat Modeling into Your Design Process
Threat modeling helps identify potential vulnerabilities before they become embedded in the product. This proactive approach reduces the need for costly post-development fixes and supports FDA and EU compliance.
3. Develop a Comprehensive SBOM Early
A complete Software Bill of Materials (SBOM) is now a regulatory requirement. Creating it early ensures transparency, streamlines vulnerability management, and avoids last-minute compliance issues.
4. Align with Global Cybersecurity Standards
Following international standards like ISO/IEC 81001-5-1 and FDA premarket guidance from the start helps reduce rework and ensures smoother regulatory submissions across markets.
5. Collaborate with Cybersecurity Experts
Partnering with experienced cybersecurity consultants can help identify risks, implement best practices, and avoid costly missteps. Expert guidance ensures your team stays ahead of evolving regulations and industry expectations.
Partner with Regulatory Compliance Associates®
Early cybersecurity planning is not just cost-effective, it’s essential for regulatory success and patient safety. By embedding cybersecurity into every stage of product development, medical device manufacturers can reduce costs, accelerate time to market, and build more secure, compliant products.
Regulatory Compliance Associates® (RCA) helps medical device companies reduce cybersecurity costs through early planning, threat modeling, SBOM development, and global regulatory strategy. Contact RCA today to learn how our experts can support your secure product development journey.
