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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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 software
Orthogonal'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 started
Teams 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 capabilities
Orthogonal'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 teams
Orthogonal'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 afterthought
Users 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 ownership
Because 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
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
See exactly how the two platforms stack up on the criteria that matter most to regulated quality teams.
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.
Switching is easy / Migrate from Orthogonal in 4 simple steps
We analyse your Orthogonal configuration and map it to Matrix Quality.
Documents, CAPA records, and training data migrated with full traceability and version history preserved.
Workflows, roles, and templates configured with IQ/OQ documentation ready.
Full onboarding with a dedicated Customer Success Manager from day one.
Stop fighting your quality system. / Start shipping safer products.
Join 500+ life sciences companies that chose Matrix Quality. Book a demo with one of our specialists today.