Services Designed for Your Success
Explore our comprehensive cybersecurity consulting services, built to secure your medical devices with precision and care.
Regulatory Compliance Consulting
Guidance on complex global cybersecurity regulations to ensure devices meet stringent security standards.
Security & Privacy by Design Services
Identify vulnerabilities early and mitigate risks with comprehensive threat analysis and risk evaluation.
Security Testing
Enhance security by integrating automated tools and performing rigorous penetration tests to ensure device security.
Integrating Cybersecurity Throughout Medical Device Development
Secure Software Development
Integrating frameworks and procedures into your quality management system to ensure security is embedded into your product from the start. Our experts will help you build a product security program aligned with global regulatory requirements like US-FDA, EU-MDR, NMDA, PMDA etc.
Comprehensive Threat Modeling
Analyzing potential threats and vulnerabilities in the design to preemptively counter cyber threats. Our experts are skilled in threat modeling diverse type of devices like implantable, diagnostic devices, treatment devices, cloud/SaaS products etc.
Security Risk Management
Assessing and mitigating cybersecurity risks tailored to medical device standards. Collaborate with R&D, Quality, and other stakeholders to effectively manage risks throughout development and post-market phases.
AppSec Integration
Deploying automated security tools within your development pipelines for continuous security assessment. Our consultants can help you choose the right solution and support integrating them working with your DevOps team to shift security to as far left as possible in the development process.
Penetration Testing
We partner with industry leading experts in conducting rigorous security tests and guiding adherence to medical regulatory standards.
Post Market Surveillance
We provide you with comprehensive post market cybersecurity support after your product is in the market. Services include monitoring of new vulnerabilities, triaging and risk assessment, generating periodic regulatory reports, coordinated vulnerability disclosure, etc.
Compliance Services
Services to help you comply with regulatory requirements and standards
HIPAA Security Rule
We help medical device companies and healthcare organizations navigate HIPAA compliance through comprehensive risk analysis. Our experts identify potential security and privacy vulnerabilities, assess the impact of risks to protected health information (PHI), and provide actionable strategies to mitigate them. By ensuring compliance with HIPAA requirements, we help safeguard patient data, reduce regulatory exposure, and strengthen trust with providers and patients alike.
US FDA Cybersecurity Regulation
We provide expert assessments of your medical devices against U.S. FDA cybersecurity requirements. Our team evaluates device design, risk management, and documentation to ensure compliance with FDA expectations, while helping you address any gaps before submission. By aligning with evolving regulatory standards, we help you accelerate approvals, protect patient safety, and maintain trust in connected medical technologies.
IEC 81001-5-1
Global regulators are increasingly expecting compliance to IEC 81001-5-1, the international standard for health software and health IT systems safety. We help medical device manufacturers and healthcare software developers achieve compliance with IEC 81001-5-1. Our assessment services evaluate your development processes, risk management practices, and documentation to ensure alignment with the standard.