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.

Essentials Package

Ideal for startups and manufacturers looking to establish a cybersecurity foundation.

• Initial organizational gap assessment against FDA/MDR cybersecurity requirements
• Recommendations for regulatory compliance improvements
• Templates for essential cybersecurity policies/procedures
• Templates for most common submission documents

Standard Package

Designed for manufacturers preparing for FDA 510(k)/PMA or MDR submissions.

• Comprehensive gap assessment & compliance roadmap
• Cybersecurity risk management and threat modeling aligned with regulatory guidance
• Drafting of key cybersecurity documents for FDA/MDR submission packages
• Review of product security testing evidence (e.g., penetration testing, SAST, DAST, SCA)
• Guidance on HIPAA/GDPR considerations where applicable

Comprehensive Package

Best suited for companies seeking full lifecycle support and regulatory confidence.

• Everything in Standard Package, plus:
• Perform independent SAST, SCA and Penetration Testing
• Direct support during regulatory queries & audits (FDA or Notified Bodies)
• Ongoing advisory support through the approval process

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.