Top 12 Best SOC 2 Providers for Medical Software Companies

Medical device software companies face a compliance landscape unlike almost any other industry. Beyond meeting FDA cybersecurity expectations and HIPAA’s strict rules around protected health information, these companies must also prove to hospitals, investors, and enterprise buyers that they handle data responsibly. That’s where finding the best SOC 2 providers for medical software companies becomes essential, since the right partner streamlines audits, accelerates sales cycles, and builds lasting trust with healthcare customers. Without a reliable provider, however, companies often struggle with messy evidence collection, drawn-out audit timelines, and compliance gaps that stall enterprise deals.

However, not every SOC 2 provider understands the unique demands that medical device software companies face, including HIPAA overlap, FDA cybersecurity expectations, and the need to manage sensitive patient data responsibly. Therefore, this article breaks down the top 12 SOC 2 providers that serve medical device software companies particularly well, examining what each platform offers, where it excels, where it falls short, and how much it costs. By the end, medical device software companies will have a clear, practical roadmap for selecting a SOC 2 partner that fits their stage of growth and compliance roadmap.

Top 12 Best SOC 2 Providers for Medical Device Software Companies

1. Scytale

Scytale stands out as a hybrid provider that combines AI-driven automation software with dedicated GRC (governance, risk, and compliance) experts who actively manage a company’s SOC 2 timeline. For medical device software companies, this hands-on advisory model proves especially valuable, since these organizations often lack a full-time compliance team capable of navigating both SOC 2 and HIPAA simultaneously. Scytale automates evidence collection across cloud infrastructure, identity providers, and HR systems, and then layers human expertise on top to interpret findings and prepare audit packages. Furthermore, Scytale maps SOC 2 controls directly to HIPAA, ISO 27001, and other frameworks, which means medical device companies can reuse the same evidence base as they expand their compliance portfolio.

Features

• AI-powered automation paired with dedicated compliance advisors who guide the audit process from start to finish
• Multi-framework control mapping across SOC 2, HIPAA, ISO 27001, GDPR, and PCI DSS
• Continuous control monitoring with real-time dashboards for executive visibility
• Pre-built policy templates tailored to healthcare technology vendors
• Auditor collaboration workspace that consolidates evidence sharing and remediation tracking

Pros

• Scytale offers strong hand-holding for first-time SOC 2 candidates, which suits medical device software teams that are simultaneously managing FDA submissions.
• The multi-framework mapping accelerates HIPAA alignment considerably.

Cons

• The combination of software and advisory services can cost more than pure self-serve platforms
• Smaller startups may find the onboarding process more involved than expected.

Pricing: Scytale does not publish pricing publicly; prospective customers must request a custom quote based on company size, framework scope, and the level of advisory support required.

2. Vanta

Vanta remains one of the most widely adopted SOC 2 compliance platforms, serving thousands of customers across healthcare, fintech, and SaaS. For medical device software companies, Vanta’s appeal lies in its enormous integration library, which connects to cloud providers, identity platforms, and development tools to automate evidence collection continuously. Vanta runs a large number of automated tests against infrastructure configurations, then alerts teams the moment a control drifts out of compliance. In addition, Vanta supports cross-mapping between SOC 2 and HIPAA, ISO 27001, and GDPR, allowing medical device vendors to build a single control library that satisfies multiple regulatory audiences at once.

Features

• Over a thousand automated tests covering security configurations across cloud and SaaS environments
• Hundreds of native integrations, including AWS, Azure, Okta, and GitHub
• AI-assisted policy generation and control mapping to accelerate audit readiness
• Continuous monitoring with real-time alerts for configuration drift

Pros

• Vanta’s broad integration ecosystem and continuous monitoring make it easy for engineering-heavy medical device teams to stay audit-ready without manual screenshotting.
• The trust center also speeds up vendor security reviews from hospital procurement teams

Cons

• Vanta is software-only, so companies still need to engage an independent CPA firm for the actual audit
• The platform may need additional support interpreting HIPAA-specific nuances.

3. Drata

Drata has built a reputation for highly automated, multi-framework compliance programs, and it integrates well into existing developer workflows. For medical device software companies running agile development cycles, Drata’s continuous control monitoring fits naturally alongside CI/CD pipelines, automatically pulling evidence from code repositories, cloud infrastructure, and ticketing systems. Drata’s platform also emphasizes turning compliance into a sales enablement asset, with shareable trust pages that demonstrate SOC 2 and HIPAA posture to enterprise health system buyers. Because medical device software often needs to prove compliance repeatedly during sales cycles, this trust-page capability reduces the burden of responding to repetitive security questionnaires.

Features

• Deep integrations with developer tools, cloud platforms, and identity providers for automated evidence capture
• Multi-framework support spanning SOC 2, HIPAA, ISO 27001, and HITRUST-aligned controls
• Risk management module that ties identified risks directly to remediation tasks
• Polished trust page for sharing compliance status with enterprise prospects
• Workflow automation for access reviews, vendor risk assessments, and employee onboarding

Pros

• Drata’s automation reduces manual evidence gathering substantially
• Its UI is considered one of the more intuitive in the category, which shortens the learning curve for compliance newcomers.

Cons

• Drata requires an external auditor for the actual SOC 2 report
• Configuring integrations for highly customized medical device infrastructure can take time

4. Secureframe

Secureframe positions itself as a strong fit for small and mid-sized businesses, and it pairs automation with built-in security awareness training and a customer-facing trust portal. For medical device software companies, this combination matters because employee security training is a control area frequently scrutinized during both SOC 2 and HIPAA audits. Secureframe automates evidence collection across cloud accounts and HR systems, then bundles policy templates that map cleanly to HIPAA Security Rule requirements. Moreover, Secureframe’s vendor risk management module helps medical device companies track third-party suppliers, which is essential given how often these companies rely on cloud hosting providers, EHR integration partners, and contract manufacturers.

Features

• Built-in security awareness training that satisfies SOC 2 and HIPAA workforce training requirements
• Automated evidence collection across cloud infrastructure, HR, and identity tools
• Vendor risk management workflows for tracking third-party suppliers and subprocessors
• Customer-facing trust portal for sharing compliance reports with healthcare partners
• Pre-mapped policy templates aligned to HIPAA, SOC 2, and ISO 27001

Pros

• As with most automation platforms, Drata requires an external auditor for the actual SOC 2 report, and configuring integrations for highly customized medical device infrastructure can take time

Cons

• Some users report that customization of policy templates for highly specialized medical device workflows requires additional manual editing.

5. Sprinto

Sprinto focuses on speed-to-compliance for early-stage and fast-growing companies, offering an AI-native GRC platform combined with dedicated compliance manager support. For medical device software startups racing toward an FDA submission while simultaneously courting enterprise customers, Sprinto’s emphasis on rapid SOC 2 Type I or Type II readiness can compress timelines significantly. Sprinto continuously monitors cloud configurations and automatically flags non-compliant settings, while its compliance managers help interpret audit findings and coordinate with external auditors. Additionally, Sprinto supports mapping across SOC 2, ISO 27001, HIPAA, and GDPR, which allows medical device companies entering European markets to address GDPR alongside their domestic compliance work.

Features

• Dedicated compliance manager support included with most plans, accelerating audit preparation
• Continuous, automated monitoring of cloud infrastructure with instant non-compliance alerts
• Multi-framework crosswalks across SOC 2, ISO 27001, HIPAA, and GDPR
• Risk register and policy management tools tailored for fast-growing teams
• Integration marketplace covering common cloud, identity, and developer platforms

Pros

• Sprinto’s compliance manager support consistently produces faster time-to-audit results for first-time SOC 2 candidates, which suits medical device startups under investor or customer pressure to certify quickly.

Cons

• The platform’s rapid-onboarding model works best for companies with relatively standard tech stacks
• Highly bespoke medical device infrastructure may need extra configuration time.

6. Thoropass

Thoropass differentiates itself through a bundled model that combines compliance automation software with an in-house audit firm, meaning customers do not need to source a separate CPA firm for their SOC 2 examination. For medical device software companies, this single-vendor approach reduces coordination overhead between the compliance platform and the auditor, since both parties operate under one roof. Thoropass automates evidence collection, policy generation, and control monitoring, while its audit team conducts the actual SOC 2 Type I and Type II examinations. Thoropass also supports HIPAA, ISO 27001, and PCI DSS, enabling medical device vendors to consolidate multiple audits with a single provider relationship.

Features

• Bundled SOC 2 audit and compliance software from a single vendor, eliminating the need to find a separate CPA firm
• Automated evidence collection and continuous monitoring across cloud environments
• Multi-framework support including HIPAA, ISO 27001, and PCI DSS
• Dedicated onboarding specialists who guide first-time SOC 2 candidates
• Audit collaboration hub shared between the compliance team and Thoropass auditors

Pros

• The bundled audit-and-software approach simplifies vendor management considerably
• Medical device companies report fewer scheduling delays since the auditor and platform team coordinate internally.

Cons

• Bundling can reduce flexibility for companies that already have an established relationship with an independent audit firm

7. Strike Graph

Strike Graph emphasizes a risk-based approach to SOC 2 readiness, helping companies build a risk register that directly informs which controls matter most for their specific business model. For medical device software companies, this risk-centric methodology aligns naturally with the risk management practices already required under FDA quality system regulations, since both frameworks emphasize identifying, assessing, and mitigating risks systematically. Strike Graph automates evidence collection, generates audit-ready documentation, and connects companies with a network of vetted auditors. Furthermore, Strike Graph’s control library maps to multiple frameworks, helping medical device vendors extend their SOC 2 work into ISO 27001 or HIPAA without rebuilding their evidence base from scratch.

Features

• Risk-based methodology that ties SOC 2 controls to a quantified risk register
• Automated evidence collection with integrations across major cloud and SaaS platforms
• Access to a network of independent auditors for SOC 2 Type I and Type II examinations
• Multi-framework control library supporting ISO 27001 and HIPAA crosswalks
• Customizable reporting that highlights risk reduction over time for executive stakeholders

Pros

• The risk-based framing resonates well with medical device companies already accustomed to risk management documentation

Cons

• Companies unfamiliar with formal risk assessment methodologies may face a steeper initial learning curve compared to more prescriptive, checklist-driven platforms.

8. Hyperproof

Hyperproof takes a broader GRC platform approach, extending beyond SOC 2 into enterprise risk management, internal audit, and vendor risk programs. For medical device software companies that anticipate scaling into larger enterprise or hospital-system customers, Hyperproof’s more comprehensive risk management capabilities can support not only SOC 2 but also the broader governance structures that larger healthcare buyers expect to see during vendor due diligence. Hyperproof automates evidence collection, maps controls across frameworks including SOC 2, HIPAA, and HITRUST-aligned criteria, and provides workflow automation for recurring compliance tasks such as access reviews and policy attestations. Its reporting capabilities also give compliance leaders detailed visibility into control health across the organization.

Features

• Comprehensive GRC platform covering compliance, risk management, and internal audit in one system
• Control mapping across SOC 2, HIPAA, ISO 27001, and HITRUST-aligned frameworks
• Workflow automation for recurring tasks like access reviews and policy attestations
• Customizable risk registers and reporting dashboards for executive and board reporting
• Integration support for cloud infrastructure, identity providers, and ticketing systems

Pros

• Hyperproof’s broader scope makes it a strong long-term investment for medical device companies

Cons

• The platform’s breadth can feel like overkill for very early-stage companies

9. Scrut Automation

Scrut Automation provides continuous compliance monitoring alongside dedicated compliance manager support, making it a popular choice for companies pursuing multiple frameworks simultaneously. For medical device software companies, Scrut’s ability to manage SOC 2, HIPAA, ISO 27001, and cloud security posture management within a single platform reduces the number of vendor relationships needed to maintain a healthy security program. Scrut automatically scans cloud infrastructure for misconfigurations, maps findings to relevant compliance controls, and generates audit-ready evidence. In addition, Scrut’s compliance managers assist with policy customization, which helps medical device vendors tailor generic templates to reflect device-specific data flows and PHI handling practices.

Features

• Continuous cloud security posture monitoring integrated with compliance control mapping
• Dedicated compliance manager support for policy customization and audit preparation
• Multi-framework coverage including SOC 2, HIPAA, ISO 27001, and GDPR
• Automated evidence collection with integrations across major cloud providers
• Vendor risk management and employee onboarding/offboarding workflows

Pros

• Combined cloud security scanning and compliance mapping in one platform

Cons

• Some smaller teams find the platform’s feature set broader than necessary

10. JupiterOne

JupiterOne differs from traditional SOC 2 automation platforms by focusing primarily on asset visibility and relationship mapping across an organization’s entire technology footprint. For medical device software companies with complex, distributed infrastructure spanning cloud environments, IoT device fleets, and third-party integrations, JupiterOne’s graph-based asset inventory provides unmatched visibility into how systems, data, and devices relate to one another. However, JupiterOne functions primarily as a security engineering tool rather than a dedicated compliance tool, so medical device companies typically need to invest engineering effort to map discovered assets to SOC 2 controls. Despite this additional configuration work, the resulting asset inventory often proves invaluable for both SOC 2 audits and FDA cybersecurity documentation, such as software bills of materials.

Features

• Graph-based asset inventory that maps relationships between devices, cloud resources, and data flows
• Strong support for software bill of materials documentation relevant to FDA cybersecurity submissions
• Continuous discovery of new assets and configuration changes across hybrid environments
• Custom query language for building tailored compliance and security reports
• API-driven architecture that integrates with existing security and DevOps

Pros

• JupiterOne’s asset visibility offers security insights that go well beyond what typical SOC 2 platforms

Cons

• JupiterOne requires significant engineering time to configure control mappings,

11. OneTrust

OneTrust is a long-established platform best known for privacy management, but it has expanded into broader GRC capabilities including SOC 2 readiness, vendor risk management, and IT risk management. For medical device software companies operating internationally, OneTrust’s deep privacy management roots make it especially useful for addressing GDPR alongside SOC 2 and HIPAA, since many medical device vendors sell into the European Union and must demonstrate compliance with data protection regulations such as GDPR Articles 30, 32, and 35. OneTrust automates evidence collection, manages data mapping and privacy impact assessments, and provides modules for vendor risk and third-party management, which helps medical device companies track the security posture of cloud hosting providers and clinical data partners.

Features

• Strong privacy management capabilities, including data mapping and privacy impact assessments for GDPR
• Vendor and third-party risk management modules suited to complex supplier networks
• SOC 2 readiness assessments integrated within a broader enterprise GRC suite
• Extensive policy and control libraries spanning multiple global regulatory frameworks
• Enterprise-grade reporting and workflow automation for large compliance teams

Pros

• OneTrust’s privacy-first heritage makes it a strong choice for medical device companies with significant international operations that must satisfy GDPR alongside SOC 2 and HIPAA

Cons

• OneTrust is generally considered an enterprise-grade platform, and its complexity and cost may exceed the needs of smaller medical device startups pursuing only SOC 2.

12. AuditBoard

AuditBoard has earned its reputation as a legacy leader among large enterprises with established internal audit departments, offering robust capabilities for SOC 2 readiness, internal controls management, and enterprise risk management. For medical device software companies that have grown into mid-size or large organizations with dedicated internal audit functions, AuditBoard provides the structured workflows, control libraries, and reporting depth that internal auditors expect. AuditBoard supports SOC 2 alongside other frameworks relevant to larger medical device companies, including SOX IT general controls, which often become relevant once a company approaches public listing or operates under stricter financial reporting requirements. While AuditBoard’s feature depth is considerable, it is generally positioned for organizations that already have mature compliance and audit teams in place.

Features

• Enterprise-grade internal audit management alongside SOC 2 and SOX ITGC support
• Robust control libraries and workflow automation suited to larger compliance teams
• Detailed reporting and dashboards designed for board-level and executive audiences
• Risk management modules that integrate with broader enterprise risk programs
• Strong support for organizations managing multiple simultaneous audits and frameworks

Pros

• AuditBoard’s depth and structure make it well suited for medical device companies that have scaled to the point of needing formal internal audit functions and SOX compliance alongside SOC 2.

Cons

• AuditBoard is robust, powerful, and expensive, and its complexity can be excessive for smaller medical device companies pursuing their first SOC 2 audit.