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The Orthogonal Alternative

The smarter alternative to Orthogonal for medical device teams

Matrix Quality is built by medical device engineers and delivers faster onboarding, richer AI tools, and end-to-end compliance — without Orthogonal's consulting dependency or unpredictable costs.

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Matrix Quality vs Orthogonal — at a glance
Matrix Quality
Orthogonal
Built for Medical Device
Purpose-built for MedTech, IVD & Life Sciences
Primarily serves medical device startups but through a consulting lens
ISO 13485 Certified
Yes — certified QMS platform
Consulting practice is ISO 13485-aligned but software certification varies
AI-powered features
AI-assisted requirements, risk detection, test generation
No meaningful AI-native capabilities in the software layer
Time to value
Days to weeks with self-serve onboarding
Weeks to months — heavily dependent on consultant availability
Integrated compliance platform
Requirements, quality, and LIMS in one platform
Consulting deliverables + lightweight software; not a unified platform
EU / global support
European team, MDR and FDA coverage
Primarily US-focused; limited EU regulatory depth

This comparison is based on publicly available information and internal analysis as of June 2026. Features and capabilities may change over time. For the most accurate and up-to-date information, you can refer to the official website of Orthogonal.

Common frustrations with Orthogonal

Teams switching from Orthogonal consistently report the same pain points.

You're paying for consultants, not softwareOrthogonal's business model is fundamentally services-led — the software is secondary to the consulting engagement. This means your QMS effectiveness is tied to consultant hours rather than a scalable platform. As your team grows or your needs evolve, costs scale with headcount on their side, not efficiency on yours.
No self-serve path to getting startedTeams looking to spin up a QMS quickly and iterate on their own hit a wall with Orthogonal. There is no meaningful self-serve onboarding — every configuration decision, every template, every workflow requires a consultant touchpoint. For startups moving fast, this creates bottlenecks that slow down product development and regulatory timelines.
Limited AI capabilitiesOrthogonal's software layer has not kept pace with modern AI tooling. There is no AI-assisted requirements analysis, no automated risk detection, and no intelligent test generation. Teams using Orthogonal are doing the same manual documentation work they would have done five years ago, while competitors leverage AI to accelerate submissions and reduce human error.
US-centric regulatory focus creates gaps for EU teamsOrthogonal's consulting practice is primarily oriented around FDA pathways. Teams pursuing CE marking under EU MDR or IVDR find that Orthogonal's templates, workflows, and consultant expertise are thinner on the European side. This forces teams with dual-market ambitions to supplement Orthogonal with additional external resources.
Software feels like an afterthoughtUsers consistently note that Orthogonal's software interface lacks the polish and depth of purpose-built QMS platforms. Features that should be standard — robust audit trails, electronic signatures compliant with 21 CFR Part 11, integrated document control with version locking — require workarounds or additional consulting effort to implement correctly.
Unpredictable total cost of ownershipBecause Orthogonal's model bundles consulting hours with software access, it is difficult to forecast annual spend. As regulatory requirements change (new FDA guidance, MDR updates, notified body feedback), the consulting meter runs. Teams that assumed a fixed SaaS cost find themselves with variable invoices tied to how complex their regulatory journey becomes.

All-in-one QMS solution managing compliance, quality, and operations

The challenge
Our solution

Maintain quality and traceability with a simple workflow

All-in-one QMS solution managing compliance, quality, and operations

  • Complex regulatory requirements

  • Data silos and inefficient processes

  • Audit readiness

  • Scalability and global operations

  • Traditional QMS validation is complex

  • Conventional QMS implementations are expensive

  • Compliance (pre-configured workflows)

  • Unified Platform (CAPAs, change management, training)

  • Real-Time Visibility (Salesforce analytics)

  • Scalable & Secure

  • Reduced validation effort

  • Low cost of ownership

    • The challenge

    Maintain quality and traceability with a simple workflow

  • Complex regulatory requirements

  • Data silos and inefficient processes

  • Audit readiness

  • Scalability and global operations

  • Traditional QMS validation is complex

  • Conventional QMS implementations are expensive

    • Our solution

    All-in-one QMS solution managing compliance, quality, and operations

  • Compliance (pre-configured workflows)

  • Unified Platform (CAPAs, change management, training)

  • Real-Time Visibility (Salesforce analytics)

  • Scalable & Secure

  • Reduced validation effort

  • Low cost of ownership

    • When writing, validating, and preparing technical documentation and audits.
    During audits thanks to Matrix Quality.
    Customers brought their products to market sooner thanks to Matrix Quality.

    See exactly how the two platforms stack up on the criteria that matter most to regulated quality teams.

    Matrix Quality
    Orthogonal

    This comparison is based on publicly available information and internal analysis as of June 2026. Features and capabilities may change over time. For the most accurate and up-to-date information, you can refer to the official website of Orthogonal.

    — Industry Fit —
    Target industries
    Medical Device, IVD, Life Sciences
    Medical device startups (primarily)
    MedTech-specific workflows
    ✅ Built-in design controls, CAPA, risk, supplier mgmt
    ⚠️ Available via consulting-configured templates
    Regulatory standards
    ✅ ISO 13485, IEC 62304, MDR, IVDR, FDA 21 CFR
    ⚠️ ISO 13485, FDA focus; EU MDR coverage is limited
    — Compliance —
    ISO 13485 certified
    ✅ Yes
    ⚠️ Consulting practice aligned; software certification not independently verified
    FDA 21 CFR Part 11
    ✅ Yes
    ⚠️ Partial — depends on consulting configuration
    Audit trail
    ✅ Full, immutable audit trail
    ⚠️ Basic audit logging; depth varies by configuration
    — Usability —
    Setup time
    ✅ Days to weeks
    ❌ Weeks to months (consultant-dependent)
    Training required
    ✅ Minimal — intuitive self-serve UI
    ❌ Significant — onboarding requires consultant guidance
    — AI Capabilities —
    AI-native
    ✅ Yes
    ❌ No
    AI features
    ✅ Requirements analysis, risk detection, test generation
    ❌ No AI-native features
    — Support —
    EU support
    ✅ Yes, European team with MDR expertise
    ⚠️ Limited EU regulatory depth; primarily US-focused
    Onboarding support
    ✅ Dedicated CSM included
    ⚠️ Consultant-led onboarding billed at hourly rates
    Book a demo →
    Matrix Quality
    — Industry Fit —
    Target industries
    Medical Device, IVD, Life Sciences
    MedTech-specific workflows
    ✅ Built-in design controls, CAPA, risk, supplier mgmt
    Regulatory standards
    ✅ ISO 13485, IEC 62304, MDR, IVDR, FDA 21 CFR
    — Compliance —
    ISO 13485 certified
    ✅ Yes
    FDA 21 CFR Part 11
    ✅ Yes
    Audit trail
    ✅ Full, immutable audit trail
    — Usability —
    Setup time
    ✅ Days to weeks
    Training required
    ✅ Minimal — intuitive self-serve UI
    — AI Capabilities —
    AI-native
    ✅ Yes
    AI features
    ✅ Requirements analysis, risk detection, test generation
    — Support —
    EU support
    ✅ Yes, European team with MDR expertise
    Onboarding support
    ✅ Dedicated CSM included
    Book a demo →
    Orthogonal
    — Industry Fit —
    Target industries
    Medical device startups (primarily)
    MedTech-specific workflows
    ⚠️ Available via consulting-configured templates
    Regulatory standards
    ⚠️ ISO 13485, FDA focus; EU MDR coverage is limited
    — Compliance —
    ISO 13485 certified
    ⚠️ Consulting practice aligned; software certification not independently verified
    FDA 21 CFR Part 11
    ⚠️ Partial — depends on consulting configuration
    Audit trail
    ⚠️ Basic audit logging; depth varies by configuration
    — Usability —
    Setup time
    ❌ Weeks to months (consultant-dependent)
    Training required
    ❌ Significant — onboarding requires consultant guidance
    — AI Capabilities —
    AI-native
    ❌ No
    AI features
    ❌ No AI-native features
    — Support —
    EU support
    ⚠️ Limited EU regulatory depth; primarily US-focused
    Onboarding support
    ⚠️ Consultant-led onboarding billed at hourly rates

    Switching is easy / Migrate from Orthogonal in 4 simple steps

    We handle the heavy lifting. Most teams are fully live in under 8 weeks.
    Free migration assessment (30 min)

    We analyse your Orthogonal configuration and map it to Matrix Quality.

    Automated data export & mapping

    Documents, CAPA records, and training data migrated with full traceability and version history preserved.

    Configure, validate & sign off

    Workflows, roles, and templates configured with IQ/OQ documentation ready.

    Go live — and keep improving

    Full onboarding with a dedicated Customer Success Manager from day one.

    “
    “I think we easily saved six months by working with Matrix One to create efficient digital workflows.”
    CV
    Carl Van Lierde
    VP Product Development, Vipun Medical
    Book your migration assessment
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    Stop fighting your quality system. / Start shipping safer products.

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