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.
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.
The challenge
Our solution
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
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
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
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