Design Control
FDA Cybersecurity Compliance Assessment
Secure. Compliant. Market-Ready. Your path to FDA-aligned cybersecurity.
With the growing connectivity of medical devices, from insulin pumps to pacemakers, cybersecurity risks have surged, posing significant threats to patient safety and data security. As devices become increasingly integrated in hospital networks and the internet, vulnerabilities to cyberattacks, such as unauthorized access or data breaches, have escalated. In response, the U.S. Food and Drug Administration (FDA) has strengthened its cybersecurity oversight through a comprehensive regulatory framework. Initiatives like FDORA Section 3305, effective March 29, 2023, and guidance on premarket and post-market cybersecurity requirements ensure manufacturers prioritize patient safety and device security throughout the Total Product Lifecycle (TPLC). These measures reflect the FDA’s commitment to safeguarding healthcare in an interconnected world.
Our FDA Cybersecurity Compliance Assessment helps medical device manufacturers navigate these regulations efficiently—covering both premarket and post-market expectations to ensure a smooth path to the U.S. market.
Your Key Benefits
What our service delivers:
- Regulatory Compliance Review: We assess your current cybersecurity practices against FDA guidance for both premarket submissions and post-market activities.
- Gap Analysis & Remediation Plan: We identify gaps in compliance and provide a clear, actionable roadmap for remediation.
- Submission Documentation Support: We assist in preparing cybersecurity sections for 510(k), De Novo, and PMA submissions—including SBOMs, risk files, and post-market surveillance plans.
- Comprehensive Final Report: You receive a complete report with findings, risk areas, compliance gaps, and tailored recommendations.
How the Process Works
- Scoped Project Kickoff: Each assessment is tailored to your specific device and risk profile.
- Gap Analysis: We highlight where current processes deviate from FDA expectations.
- Remediation Roadmap: You get a prioritized action plan to achieve full compliance.
- Final Compliance Report: Includes detailed insights and long-term strategies to maintain regulatory alignment.
Why Work with Us
- Cybersecurity + Regulatory Expertise: Our team blends technical cybersecurity know-how with deep FDA regulatory experience.
- Up-to-date & Standard-driven: We follow best practices aligned with ISO 14971, AAMI TIR57, AAMI TIR97, and IEC 81001-5-1—ensuring your compliance is always current.
- Scalable for All Manufacturers: From startups to global manufacturers, we offer flexible services for all device types and risk classes.
News
Cybersecurity for Connected Medical Devices: Regulations, Standards, and Technologies in 2025
Cybersecurity for connected medical devices: meet MDR, NIS2 & FDA requirements, minimize risks, and protect patient safety in 2025.
Scientific Writing for In Vitro Diagnostic Manufacturers
Why Professional Support in Writing Scientific Documents for Technical Documentation Is Helpful
Usability Engineering: More Than Just Compliance – A True Success Factor
Usability engineering for medical devices: Important regulatory requirements, IEC 62366, UX aspects, and best practices for safe, effective designs.
AI in medical devices – Principles and requirements of the EU AI Act
Artificial intelligence in medical devices offers great potential – and new obligations. Discover how the EU AI Act impacts MedTech companies and what it takes to implement AI systems that are safe, compliant, and future-ready.