Webinar: From Paper to eIFU: Preparing for the Next Global Step in Medical Device Compliance
Polarion Software Alternative
The smarter alternative to Polarion for life science teams
Built by medical device engineers, Matrix Req delivers faster onboarding, richer AI tools, and end-to-end compliance — without Polarion's complexity or cost.
Matrix Req vs Polarion ALM / Requirements — at a glance
Matrix Req
Jama Connect
Built specifically for MedTech / SxMD
✓ Yes
Engineering ALM
ISO 13485 certified vendor
✓ Yes
✗ No
AI with zero data retention
✓ Yes
✗ Limited
Time to value
≤ 60 days
6–12 months
Integrated eQMS
✓ Built-in
✗ Not included
Two separate products needed
✓ One platform
ALM + Req. separately
Common frustrations with Polarion
Teams switching from Polarion consistently report the same pain points.
Two products, one headachePolarion splits ALM and Requirements into separate products. Full lifecycle coverage means buying, configuring, and maintaining two separate tools — adding licensing cost and administrative overhead your team doesn't need.
Months-long implementationPolarion's enterprise setup typically requires professional services engagements and 6–12 months of configuration before teams can work productively — time your medical device project simply can't afford.
Steep learning curvePolarion's interface was built for power users and engineers, not the regulatory affairs, quality, or clinical teams who need to collaborate daily. Expect months of training before real adoption takes hold.
Zero AI capabilitiesPolarion has no AI-powered features whatsoever — no requirements generation, no traceability gap analysis, no compliance checking automation. Every gap must be found and resolved manually.
Medical compliance requires a separate MedPackOut of the box, Polarion is a general engineering ALM tool. Achieving medical device compliance (IEC 62304, ISO 14971, EU MDR) requires purchasing and configuring the separate MedPack add-on — increasing cost and setup time further.
Opaque enterprise pricingPolarion's pricing is entirely quote-based, with separate licensing for ALM vs Requirements. Budget planning is difficult, scaling triggers surprise costs, and there's no transparent starting point for smaller MedTech teams.
The challenge
Our solution
28%
Time saved
When writing, validating, and preparing technical documentation and audits.
91%
Customers feel more confident
During audits thanks to Matrix Req.
50%
Faster products launches
Customers brought their products to market sooner thanks to Matrix Req
See exactly how the two platforms stack up on the criteria that matter most to regulated product teams.
Matrix Req
Polarion ALM / Requirements
— INDUSTRY FIT —
Built specifically for medical devices / SxMD
✔
MedPack add-on required
Native ISO 14971 risk framework
✔
Partial (via MedPack)
510(k) / PMA / CE Mark workflow templates
✔
Partial (via MedPack)
EU MDR & IVDR specific support
✔
✗
ALM + Requirements in a single product
✔
✗ Two separate products
Compliance & Certifications
ISO 13485 certified vendor
✔
✗
ISO/IEC 27001 certified
✔
✔
21 CFR Part 11 electronic signatures
✔
✔
EU Annex 11 compliance
✔
Partial
Full audit trail & version control
✔
✔
Usability & Onboarding
Intuitive UI designed for non-technical users
✔
✗
Time-to-value
≤ 60 days
6–12 months
Guided data migration service
✔
✗
Excel & Word import
✔
✔
Artificial Intelligence
AI-powered requirements generation
✔
✗
AI traceability gap analysis
✔
✗
Zero data retention (your IP stays yours)
✔
✗
NLP quality checks
✔
✗
Platform & Integrations
Integrated eQMS (CAPAs, deviations, training)
✔
✗
Jira / Confluence / Azure DevOps integration
✔
✔
One-click Design History File export
✔
✗
Performance at scale (10k+ items)
✔
✔
Support & Service
European in-timezone support
✔
Partial
Dedicated customer success manager
✔
✗
Matrix Req
— INDUSTRY FIT —
Built specifically for medical devices / SxMD
✔
Native ISO 14971 risk framework
✔
510(k) / PMA / CE Mark workflow templates
✔
EU MDR & IVDR specific support
✔
ALM + Requirements in a single product
✔
Compliance & Certifications
ISO 13485 certified vendor
✔
ISO/IEC 27001 certified
✔
21 CFR Part 11 electronic signatures
✔
EU Annex 11 compliance
✔
Full audit trail & version control
✔
Usability & Onboarding
Intuitive UI designed for non-technical users
✔
Time-to-value
≤ 60 days
Guided data migration service
✔
Excel & Word import
✔
Artificial Intelligence
AI-powered requirements generation
✔
AI traceability gap analysis
✔
Zero data retention (your IP stays yours)
✔
NLP quality checks
✔
Platform & Integrations
Integrated eQMS (CAPAs, deviations, training)
✔
Jira / Confluence / Azure DevOps integration
✔
One-click Design History File export
✔
Performance at scale (10k+ items)
✔
Support & Service
European in-timezone support
✔
Dedicated customer success manager
✔
Polarion ALM / Requirements
— INDUSTRY FIT —
Built specifically for medical devices / SxMD
MedPack add-on required
Native ISO 14971 risk framework
Partial (via MedPack)
510(k) / PMA / CE Mark workflow templates
Partial (via MedPack)
EU MDR & IVDR specific support
✗
ALM + Requirements in a single product
✗ Two separate products
Compliance & Certifications
ISO 13485 certified vendor
✗
ISO/IEC 27001 certified
✔
21 CFR Part 11 electronic signatures
✔
EU Annex 11 compliance
Partial
Full audit trail & version control
✔
Usability & Onboarding
Intuitive UI designed for non-technical users
✗
Time-to-value
6–12 months
Guided data migration service
✗
Excel & Word import
✔
Artificial Intelligence
AI-powered requirements generation
✗
AI traceability gap analysis
✗
Zero data retention (your IP stays yours)
✗
NLP quality checks
✗
Platform & Integrations
Integrated eQMS (CAPAs, deviations, training)
✗
Jira / Confluence / Azure DevOps integration
✔
One-click Design History File export
✗
Performance at scale (10k+ items)
✔
Support & Service
European in-timezone support
Partial
Dedicated customer success manager
✗
Switching is easy
Migrate from Polarion in 4 simple steps
We handle the heavy lifting. Most teams are fully live in under 60 days.
Free migration assessment (30 min) — We analyse your Jama project structure and map it to Matrix Req.
Automated data export & mapping — Requirements, risks, tests, and traces migrated with full traceability.
Configure, validate & sign off — Workflows, roles, and templates configured with IQ/OQ documentation.
Go live — and keep improving — Full onboarding with a dedicated Customer Success Manager.
Book your migration assessment
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ZimbabweThank you! We'll be in touch shortly to schedule your migration assessment.
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