We help teams understand what their compliance frameworks actually require — technically — and build programs that satisfy auditors without creating organizational paralysis.
Compliance is not a destination — it's an ongoing program that intersects with how your team builds and operates software. We translate regulatory requirements into engineering work, help you prioritize the controls that matter, and produce the documentation evidence that auditors and regulatory reviewers expect to see.
The Health Insurance Portability and Accountability Act sets the baseline for protecting electronic Protected Health Information (ePHI). For any organization that handles patient data — providers, payers, health tech companies, and their business associates — HIPAA compliance is both a legal requirement and a patient trust obligation.
We help organizations understand and implement the Administrative, Physical, and Technical safeguards required by the HIPAA Security Rule, and prepare for OCR audits or business associate agreements.
Talk to Us About HIPAAFormal risk analysis of ePHI across your systems, with documented risk management plans aligned to HIPAA requirements.
Access control implementation, audit logging, encryption requirements, and automatic logoff — mapped to your specific technology stack.
Breach notification procedures, incident response plan development, and documentation requirements for HIPAA breach reporting.
Technical control verification to support Business Associate Agreements with covered entities, including evidence documentation.
The FDA's 2023 cybersecurity guidance and Section 524B of the Federal Food, Drug, and Cosmetic Act significantly raised the bar for connected medical devices. Manufacturers submitting 510(k), De Novo, or PMA applications must now provide comprehensive cybersecurity documentation demonstrating a Secure Product Development Lifecycle.
We have direct experience supporting medical device manufacturers with pre-market and post-market cybersecurity requirements — including devices with embedded firmware, wireless communication interfaces, and cloud connectivity.
Discuss Your SubmissionDocumentation aligned with ISO 14971 — threat modeling, attack surface analysis, risk controls, and residual risk acceptance.
Software Bill of Materials creation, third-party component vulnerability tracking, and update mechanism security review.
Review and documentation of your secure development lifecycle against FDA expectations — from design controls through post-market surveillance.
Penetration testing and vulnerability assessment aligned to FDA pre-market submission requirements, with findings documentation suitable for regulatory review.
Security assessment of Wi-Fi, Bluetooth, and BLE interfaces with documentation of safeguards against unauthorized access, replay, and spoofing attacks.
Ongoing vulnerability monitoring, coordinated disclosure program support, and post-market cybersecurity update documentation for regulatory compliance.
The NIST CSF provides a risk-based approach to managing cybersecurity that works for organizations of any size. Its five core functions — Identify, Protect, Detect, Respond, Recover — create a structured foundation for building and maturing a cybersecurity program.
We help organizations perform NIST CSF assessments, identify gaps relative to their target profile, and build prioritized roadmaps for improving their cybersecurity posture. NIST CSF alignment is also frequently referenced in FDA medical device guidance and other regulatory contexts.
Start a NIST AssessmentAsset inventory, data flow mapping, risk assessment, and governance — building a clear picture of your cybersecurity landscape.
Access control, data security, training, maintenance, and protective technology — implementing controls to limit the impact of a cybersecurity event.
Continuous monitoring, anomaly detection, and detection process implementation — identifying cybersecurity events in a timely manner.
Response planning, communications, analysis, mitigation, and improvement — containing the impact of detected cybersecurity events.
Recovery planning, improvements, and communications — restoring capabilities and services impaired by a cybersecurity incident.
Current state vs. target profile gap analysis, with a prioritized roadmap for closing gaps based on your risk tolerance and budget.
SOC 2 Type II is increasingly a requirement for enterprise sales — and a meaningful security certification for B2B SaaS companies. The path to SOC 2 is not just a documentation exercise; it requires your team to implement and demonstrate operating effectiveness of security controls over time.
We help engineering and security teams prepare for SOC 2 audits by identifying control gaps, building the technical evidence required by auditors, and ensuring your monitoring and logging capabilities meet the continuous oversight expectations of Type II certification.
Begin SOC 2 ReadinessThe Payment Card Industry Data Security Standard applies to any organization that stores, processes, or transmits cardholder data. PCI DSS v4.0 places new emphasis on customized security approaches, increased continuous monitoring requirements, and stronger authentication controls.
We help organizations understand their cardholder data environment (CDE) scope, implement the technical controls required by PCI DSS, and prepare for QSA assessments — with particular focus on network security, vulnerability management, and logging requirements where our tooling and expertise are directly applicable.
Discuss PCI DSS Readiness