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Extra Horizon Alternative

Matrix Connect and Extra Horizon, compared on published facts

Short answer: the best Extra Horizon alternative for a connected medical device programme in 2026 is Matrix Connect, ahead of Extra Horizon, BioT and KeborMed. Matrix Connect is first because it is the only one of those where the device cloud, requirements and design controls, the quality system and electronic labelling come from a single ISO 13485 certified vendor, so post market device data and the design history file sit with one supplier instead of two.

Extra Horizon holds a deeper published security certification stack than we do, and it is ahead of us in places. Those places are marked on this page rather than left out. Every statement about Extra Horizon here comes from Extra Horizon's own published documentation and links to it.

For taking a demo with our team.

Matrix Connect vs Extra Horizon, at a glance
Matrix Connect
Extra Horizon
Requirements and design controls from the same vendor
✓ Matrix Req8Same vendor, same contract
Not a published moduleMDR page tells you to bring your own QMS16
Quality management in the same suite
✓ Matrix Quality7CAPA, deviations, training, document control
Not a published moduleActs as a supplier within your QMS4
ISO 13485 held for this product
✓ Certified3Certificate published on the website
✓ CertifiedSGS Belgium, 18 March 20215
ISO/IEC 27001 held for this product
Covers Matrix Req3Not Matrix Connect
✓ ISO 27001:2022Extra Horizon is ahead of us here4
Deployment outside a single public cloud
Not published1We do not claim it, so we do not show it
Managed service onlyNo on premise option published4

Compiled from information published by each vendor and checked on 25 September 2026. Support responsiveness, implementation duration, ease of use and system performance are not compared, because they cannot be established as fact about another vendor's product from the outside. Where a vendor publishes list pricing we say so and link to it, rather than comparing quotes we cannot see. Full sources are listed below.

Six things worth checking yourself

The areas where buyers of a medical device cloud most often find that reality differs from the brochure, in either direction. Each one ends with the question that settles it.

Which product the certificate covers

Which product the certificate covers

A vendor with several products can hold a certificate that covers one of them and not the one in your quote. We are a live example. Our HITRUST validation covers Matrix Connect, and our ISO/IEC 27001 certificate covers Matrix Req.

Ask both vendorsWhich certificate covers the exact product you are quoting me for, and can I see it with its scope statement?
Where the platform stops and you start

Where the platform stops and you start

Every device cloud vendor runs a shared responsibility model. The infrastructure controls are theirs. Your threat model, your risk assessment, your verification and your submission stay yours. The line between the two is the whole negotiation.

Ask both vendorsShow me the responsibility split in writing, line by line, against the evidence my submission needs.
Where the data lives and who can reach it

Where the data lives and who can reach it

Patient data in a regulated device cloud crosses regions, subprocessors and support teams. Contracts settle this, brochures do not.

Ask both vendorsWhich regions will our data sit in, who are your subprocessors, and will you sign a BAA and a DPA before we commit?
The bill at production volume, not pilot volume

The bill at production volume, not pilot volume

Entry tiers are priced for a handful of devices in development. Production means redundancy, higher device counts and cloud infrastructure billed on top of the platform.

Ask both vendorsPrice a realistic production deployment at our device count, with redundancy and infrastructure costs included.
What you can actually put in a submission

What you can actually put in a submission

Design history files, software lifecycle records, a software bill of materials and cybersecurity documentation all get promised. What differs is how much arrives ready and how much your team assembles.

Ask both vendorsShow me the exact documents you hand over, and tell me which of them have already gone through a regulatory review.
Getting your device data back out

Getting your device data back out

Getting data in is well supported everywhere, because every vendor wants it. Getting it out, with device history and audit trail intact, is the question that protects you in three years.

Ask both vendorsIf we leave, what format does our device data come out in, and does the audit trail survive the export?

Connected device programmes run aground in the same six places, and Matrix Connect is built around them.

The challenge

Getting a regulated device onto the cloud, and keeping it there

  • Building the cloud yourself costs more than the estimateA compliant device cloud is not one project. It is infrastructure, security certification, monitoring, penetration testing and a team to keep all of it current. Both vendors on this page publish a build versus buy comparison because the in house number surprises people every time.
  • Security evidence arrives late and holds up the submissionCybersecurity documentation, a software bill of materials and a lifecycle record are now expected at submission, not after it. Teams that leave the cloud layer until the end find the evidence is the thing that moves the date.
  • The device cloud and the quality system never quite meetComplaints, field data and post market surveillance come from the device. CAPA, change control and the design history file live in a different system, often from a different vendor, so the handover is manual and someone owns it as a job.
  • Pilot architecture does not survive commercial volumeWhat holds up for fifty devices in a study behaves differently at tens of thousands across several regions, and rebuilding the data model after clearance is expensive.
  • Every new market adds another set of rulesFDA, EU MDR, IVDR, Health Canada, TGA and the privacy regimes that come with them. Each one wants evidence, and the evidence has to agree with itself.
  • The connectivity team you need is hard to hireCloud engineers who also understand IEC 62304, ISO 14971 and HIPAA are scarce, expensive and usually already employed.

Our solution

One certified vendor for the cloud, the design controls and the quality system

  • A device cloud you configure instead of buildModel your device data, set up collection workflows, roles and dashboards in the platform. Connect the device with the native SDK or the web API. Customers describe getting connected in weeks rather than months.
  • Certification you inheritMatrix Connect is developed and operated under an ISO 13485:2016 certified quality system, with development compliant with IEC 62304 and ISO 14971, and it is HITRUST CSF r2 validated. The certificates are published on our website, not offered on request.
  • Post market data that lands next to your quality recordsMatrix Quality gives you CAPA, deviations, complaints, change control, training and controlled documents from the same vendor as the cloud, so device evidence and quality evidence do not live in two companies.
  • Design controls in the same suiteMatrix Req covers requirements, risk to ISO 14971, verification and validation and design history file output, so the trace from a field event back to a requirement stays inside one supplier relationship.
  • Built for Class III as well as wellnessMatrix Connect already supports Class III implantable and life sustaining devices in production, including LVADs, neurostimulators and cardiac monitoring.
  • Clearances our customers already holdCustomers using Matrix Connect have obtained US FDA clearance, CE Mark under EU MDR and IVDR, Health Canada and Australian TGA approvals, and sell on six continents.
6 months
Saved on the cloud build
Greg O'Grady, CEO of Alimetry: "It would have been at least six months building cloud connectivity from scratch." [10]
500+
Life sciences companies
Matrix One is used by more than 500 life sciences and medical device companies across its product suite. [1]
6
Continents in production
Matrix Connect customers sell their devices across all six inhabited continents and multiple regulatory jurisdictions. [14]

How the two platforms compare on criteria that can be verified against each vendor's published documentation. Where both platforms do the same thing, the table says so, rather than leaving a blank that reads as a gap. Where Extra Horizon is ahead, the table says that too.

Matrix Connect
Extra Horizon
Industry fit
Built only for medical devices and life sciences
YesEvery product in the Matrix One suite serves life sciences only. 1
YesExtra Horizon describes itself as a backend platform built for regulated medical software. 2
Supports Class III and life sustaining devices
YesAlready in production on Class III implantable and life sustaining devices, including LVADs, neurostimulators and cardiac monitoring. 9
Not publishedExtra Horizon does not publish a device class scope for the platform. 2
Customer devices cleared by regulators on the platform
YesCustomers have obtained FDA clearance, CE Mark, EU MDR, IVDR, Health Canada and Australian TGA approvals. 6
YesExtra Horizon states that customers have achieved CE Marking, FDA compliance, GDPR compliance and HIPAA compliance using the platform. 4
Compliance and certifications
ISO 13485 held by the vendor for this product
CertifiedMatrix Connect is developed and operated under an ISO 13485:2016 certified quality system. The certificate is published on our website. 3
CertifiedISO 13485:2016, certified by SGS Belgium on 18 March 2021, announced on Extra Horizon's own blog. 5
HITRUST CSF validated
CertifiedHITRUST CSF r2 validated, and the validation covers Matrix Connect specifically. 3
Not publishedHITRUST does not appear in Extra Horizon's published certification list. 4
SOC 2 Type II attestation
Not publishedMatrix One does not publish a SOC 2 Type II attestation. 3
Not publishedExtra Horizon does not publish a SOC 2 Type II attestation. 4
ISO/IEC 27001 held for this product
DiffersMatrix One holds ISO/IEC 27001:2022, and the certificate covers Matrix Req rather than Matrix Connect. 3
YesISO 27001:2022 and ISO 27701:2019, both in Extra Horizon's published certification list. Extra Horizon is ahead of us on this one. 4
IEC 62304 software lifecycle
YesDevelopment processes compliant with IEC 62304 and ISO 14971. 6
YesIEC 62304:2015, in the published certification list. 4
HIPAA and GDPR
YesMatrix Connect adheres to HIPAA and complies with GDPR for EU and UK personal data. 6
YesCustomers have achieved GDPR and HIPAA compliance on the platform, and Extra Horizon also holds an HDS health data hosting certification. 4
Platform capability
Configure data models and workflows without writing code
YesDevice data modelling is a configuration tool for building custom data collection workflows per device. 1
Not publishedExtra Horizon publishes an SDK, a CLI and a Control Center for environment management rather than a no code configuration tool. 15
Device SDK and web API
YesNative SDK plus a modular web API for third party systems. 1
YesA JavaScript SDK, a CLI for CI/CD integration and documented platform services. 15
Remote monitoring with alerts and notifications
YesReal time alerts and notifications with a mobile friendly portal. 1
YesReports and notifications are a named platform feature, built on the Task Service and event based logic. 2
Role based access for clinicians, patients and families
YesRole based access with customisable data visibility for providers, patients and families. 1
YesRole based permissions through a named Authorization Service. 2
Dashboards, analytics and data export
YesConfigurable dashboards and data exports. 1
YesA statistics database and data visualisation for medical analytics. 2
EHR and EMR integration
YesEHR and EMR connections through standardised APIs. 1
Not publishedExtra Horizon does not name FHIR or HL7 support in its published service list. 2
Deployment outside a single public cloud
Not publishedMatrix One does not publish an on premise or multi cloud deployment option for Matrix Connect. 1
NoManaged service only. Extra Horizon states that each customer gets its own cloud cluster and dedicated VPC with multi region data residency, and that no on premise or unmanaged option is available. 4
Design controls, quality and labelling in the same suite
Requirements management and design controls from the same vendor
YesMatrix Req, sold and supported by the same company as the cloud. 8
Not a published moduleRequirements management and design controls are not part of Extra Horizon's published service list. Its MDR page tells customers they need a quality management system of their own in place. 16
CAPA, deviations, complaints and change control
YesMatrix Quality. 7
Not a published moduleNot listed in Extra Horizon's published service set. 2
Training management and controlled documents
YesMatrix Quality. 7
Not a published moduleNot listed in Extra Horizon's published service set. 2
Risk management to ISO 14971 in the same suite
YesMatrix Req covers hazard analysis and risk to ISO 14971. 8
Not a published moduleExtra Horizon holds IEC 62304 certification for its own development, which is not the same as risk management tooling for your device. 4
Electronic instructions for use and labelling
YesMatrix eIFU, from the same vendor. 13
Not a published moduleNot listed in Extra Horizon's published service set. 2
Post market device data linked to quality records under one contract
YesThe cloud, the quality system and the design history file all come from Matrix One. 7
Not a published moduleExtra Horizon acts as a critical supplier within your quality management system rather than providing one, so quality records sit with a second vendor. 4
Commercial and company
List pricing published
NoMatrix One quotes per customer through a pricing request rather than publishing tiers. 11
NoExtra Horizon does not publish list pricing. 4
Published build versus buy cost comparison
YesA total cost of ownership calculator comparing Matrix Connect with an in house build. 1
Not publishedExtra Horizon does not publish a build versus buy cost comparison. 4
Track record in medical device cloud connectivity
YesMatrix Connect is the former Galen Data platform, founded in Houston in 2016 and acquired by Matrix One in 2024. Matrix One has served regulated product development since 2014. 12
YesExtra Horizon has held ISO 13485 certification since March 2021 and positions itself as a supplier to MDR and IVDR regulated manufacturers. 5
Matrix Connect
Industry fit
Built only for medical devices and life sciences
YesEvery product in the Matrix One suite serves life sciences only. 1
Supports Class III and life sustaining devices
YesAlready in production on Class III implantable and life sustaining devices, including LVADs, neurostimulators and cardiac monitoring. 9
Customer devices cleared by regulators on the platform
YesCustomers have obtained FDA clearance, CE Mark, EU MDR, IVDR, Health Canada and Australian TGA approvals. 6
Compliance and certifications
ISO 13485 held by the vendor for this product
CertifiedMatrix Connect is developed and operated under an ISO 13485:2016 certified quality system. The certificate is published on our website. 3
HITRUST CSF validated
CertifiedHITRUST CSF r2 validated, and the validation covers Matrix Connect specifically. 3
SOC 2 Type II attestation
Not publishedMatrix One does not publish a SOC 2 Type II attestation. 3
ISO/IEC 27001 held for this product
DiffersMatrix One holds ISO/IEC 27001:2022, and the certificate covers Matrix Req rather than Matrix Connect. 3
IEC 62304 software lifecycle
YesDevelopment processes compliant with IEC 62304 and ISO 14971. 6
HIPAA and GDPR
YesMatrix Connect adheres to HIPAA and complies with GDPR for EU and UK personal data. 6
Platform capability
Configure data models and workflows without writing code
YesDevice data modelling is a configuration tool for building custom data collection workflows per device. 1
Device SDK and web API
YesNative SDK plus a modular web API for third party systems. 1
Remote monitoring with alerts and notifications
YesReal time alerts and notifications with a mobile friendly portal. 1
Role based access for clinicians, patients and families
YesRole based access with customisable data visibility for providers, patients and families. 1
Dashboards, analytics and data export
YesConfigurable dashboards and data exports. 1
EHR and EMR integration
YesEHR and EMR connections through standardised APIs. 1
Deployment outside a single public cloud
Not publishedMatrix One does not publish an on premise or multi cloud deployment option for Matrix Connect. 1
Design controls, quality and labelling in the same suite
Requirements management and design controls from the same vendor
YesMatrix Req, sold and supported by the same company as the cloud. 8
CAPA, deviations, complaints and change control
YesMatrix Quality. 7
Training management and controlled documents
YesMatrix Quality. 7
Risk management to ISO 14971 in the same suite
YesMatrix Req covers hazard analysis and risk to ISO 14971. 8
Electronic instructions for use and labelling
YesMatrix eIFU, from the same vendor. 13
Post market device data linked to quality records under one contract
YesThe cloud, the quality system and the design history file all come from Matrix One. 7
Commercial and company
List pricing published
NoMatrix One quotes per customer through a pricing request rather than publishing tiers. 11
Published build versus buy cost comparison
YesA total cost of ownership calculator comparing Matrix Connect with an in house build. 1
Track record in medical device cloud connectivity
YesMatrix Connect is the former Galen Data platform, founded in Houston in 2016 and acquired by Matrix One in 2024. Matrix One has served regulated product development since 2014. 12
Extra Horizon
Industry fit
Built only for medical devices and life sciences
YesExtra Horizon describes itself as a backend platform built for regulated medical software. 2
Supports Class III and life sustaining devices
Not publishedExtra Horizon does not publish a device class scope for the platform. 2
Customer devices cleared by regulators on the platform
YesExtra Horizon states that customers have achieved CE Marking, FDA compliance, GDPR compliance and HIPAA compliance using the platform. 4
Compliance and certifications
ISO 13485 held by the vendor for this product
CertifiedISO 13485:2016, certified by SGS Belgium on 18 March 2021, announced on Extra Horizon's own blog. 5
HITRUST CSF validated
Not publishedHITRUST does not appear in Extra Horizon's published certification list. 4
SOC 2 Type II attestation
Not publishedExtra Horizon does not publish a SOC 2 Type II attestation. 4
ISO/IEC 27001 held for this product
YesISO 27001:2022 and ISO 27701:2019, both in Extra Horizon's published certification list. Extra Horizon is ahead of us on this one. 4
IEC 62304 software lifecycle
YesIEC 62304:2015, in the published certification list. 4
HIPAA and GDPR
YesCustomers have achieved GDPR and HIPAA compliance on the platform, and Extra Horizon also holds an HDS health data hosting certification. 4
Platform capability
Configure data models and workflows without writing code
Not publishedExtra Horizon publishes an SDK, a CLI and a Control Center for environment management rather than a no code configuration tool. 15
Device SDK and web API
YesA JavaScript SDK, a CLI for CI/CD integration and documented platform services. 15
Remote monitoring with alerts and notifications
YesReports and notifications are a named platform feature, built on the Task Service and event based logic. 2
Role based access for clinicians, patients and families
YesRole based permissions through a named Authorization Service. 2
Dashboards, analytics and data export
YesA statistics database and data visualisation for medical analytics. 2
EHR and EMR integration
Not publishedExtra Horizon does not name FHIR or HL7 support in its published service list. 2
Deployment outside a single public cloud
NoManaged service only. Extra Horizon states that each customer gets its own cloud cluster and dedicated VPC with multi region data residency, and that no on premise or unmanaged option is available. 4
Design controls, quality and labelling in the same suite
Requirements management and design controls from the same vendor
Not a published moduleRequirements management and design controls are not part of Extra Horizon's published service list. Its MDR page tells customers they need a quality management system of their own in place. 16
CAPA, deviations, complaints and change control
Not a published moduleNot listed in Extra Horizon's published service set. 2
Training management and controlled documents
Not a published moduleNot listed in Extra Horizon's published service set. 2
Risk management to ISO 14971 in the same suite
Not a published moduleExtra Horizon holds IEC 62304 certification for its own development, which is not the same as risk management tooling for your device. 4
Electronic instructions for use and labelling
Not a published moduleNot listed in Extra Horizon's published service set. 2
Post market device data linked to quality records under one contract
Not a published moduleExtra Horizon acts as a critical supplier within your quality management system rather than providing one, so quality records sit with a second vendor. 4
Commercial and company
List pricing published
NoExtra Horizon does not publish list pricing. 4
Published build versus buy cost comparison
Not publishedExtra Horizon does not publish a build versus buy cost comparison. 4
Track record in medical device cloud connectivity
YesExtra Horizon has held ISO 13485 certification since March 2021 and positions itself as a supplier to MDR and IVDR regulated manufacturers. 5

Sources for this comparison

  1. 1Matrix One, Matrix Connect product page. https://matrixone.health/products/matrix-connect
  2. 2Extra Horizon, medical backend as a service platform. https://extrahorizon.com/platform/medical-baas
  3. 3Matrix One, compliance and certifications, with the certificates published in full. https://matrixone.health/compliance-certifications
  4. 4Extra Horizon, frequently asked questions, including its certification list and hosting model. https://extrahorizon.com/faq
  5. 5Extra Horizon, ISO 13485:2016 certification announcement, 18 March 2021. https://extrahorizon.com/blog/iso-13485-certification-mdr-ivdr
  6. 6Matrix One, Matrix Connect compliant cloud platform. https://matrixone.health/connect/compliant-cloud-platform
  7. 7Matrix One, Matrix Quality product page. https://matrixone.health/products/matrix-quality
  8. 8Matrix One, Matrix Req product page. https://matrixone.health/products/matrix-req
  9. 9Matrix One, Matrix Connect for Class III connected devices. https://matrixone.health/connect/class-iii-connected-devices
  10. 10Matrix One, Alimetry customer story. https://matrixone.health/customer-success-stories/-matrix-connect-alimetry-case-study
  11. 11Matrix One, pricing request page. https://matrixone.health/get-pricing
  12. 12Matrix One, about us and company timeline. https://matrixone.health/about-us
  13. 13Matrix One, Matrix eIFU product page. https://matrixone.health/products/matrix-eifu
  14. 14Matrix One, Matrix Connect scalability and uptime. https://matrixone.health/connect/scalability-and-uptime
  15. 15Extra Horizon, platform architecture. https://extrahorizon.com/platform/architecture/
  16. 16Extra Horizon, EU MDR compliance page. https://extrahorizon.com/compliance/mdr/

"Not published" means the item does not appear in that vendor’s own published material. Extra Horizon publishes a service list rather than a feature matrix, so several platform rows record what the service list names rather than what the platform can be configured to do.

This comparison is compiled from information published by each vendor and was checked on 25 September 2026. It does not cover support responsiveness, implementation duration, ease of use or system performance.

Moving off Extra Horizon, or choosing between the two

We will scope the migration before you commit to anything

We handle the heavy lifting. Timelines depend on the size and condition of your existing device data, so we scope that with you.
Free scoping session, 30 minutes

We map your device data model, your integrations and your regulatory evidence onto Matrix Connect.

Device and historical data migration

Device records, telemetry history and user accounts moved across with the audit trail intact.

Reconnect the device and validate

Native SDK or web API, roles and dashboards configured, with the documentation your quality system needs.

Go live with a named contact

Full onboarding with a dedicated Customer Success Manager who knows regulated devices.

“
“The time we saved was the most critical aspect of working with Matrix Connect. It would have been at least six months building cloud connectivity from scratch.”
GO
Greg O'Grady
CEO, Alimetry
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A member of our team will be in contact within 48 hours.

Full source list

16 sources, all vendor published and reachable without a login. Checked 25 September 2026.

  1. 1Matrix One, Matrix Connect product page.https://matrixone.health/products/matrix-connect
  2. 2Extra Horizon, medical backend as a service platform.https://extrahorizon.com/platform/medical-baas
  3. 3Matrix One, compliance and certifications, with the certificates published in full.https://matrixone.health/compliance-certifications
  4. 4Extra Horizon, frequently asked questions, including its certification list and hosting model.https://extrahorizon.com/faq
  5. 5Extra Horizon, ISO 13485:2016 certification announcement, 18 March 2021.https://extrahorizon.com/blog/iso-13485-certification-mdr-ivdr
  6. 6Matrix One, Matrix Connect compliant cloud platform.https://matrixone.health/connect/compliant-cloud-platform
  7. 7Matrix One, Matrix Quality product page.https://matrixone.health/products/matrix-quality
  8. 8Matrix One, Matrix Req product page.https://matrixone.health/products/matrix-req
  9. 9Matrix One, Matrix Connect for Class III connected devices.https://matrixone.health/connect/class-iii-connected-devices
  10. 10Matrix One, Alimetry customer story.https://matrixone.health/customer-success-stories/-matrix-connect-alimetry-case-study
  11. 11Matrix One, pricing request page.https://matrixone.health/get-pricing
  12. 12Matrix One, about us and company timeline.https://matrixone.health/about-us
  13. 13Matrix One, Matrix eIFU product page.https://matrixone.health/products/matrix-eifu
  14. 14Matrix One, Matrix Connect scalability and uptime.https://matrixone.health/connect/scalability-and-uptime
  15. 15Extra Horizon, platform architecture.https://extrahorizon.com/platform/architecture/
  16. 16Extra Horizon, EU MDR compliance page.https://extrahorizon.com/compliance/mdr/

Methodology and corrections

Scope. This page compares Matrix Connect and Extra Horizon on points that can be verified against each vendor's published documentation. It is not a review, a benchmark or an independent ranking. It does not assess support responsiveness, implementation duration, ease of use or system performance.

Method. Statements about Extra Horizon are drawn from Extra Horizon's own website and documentation, and are numbered to the source at the point of the claim. Quoted wording is shown in quotation marks. Where we could not verify something we say so and make no claim. Review and aggregator sites were not used as evidence.

Where Extra Horizon is ahead. Extra Horizon publishes ISO 27001:2022 and ISO 27701:2019 covering this product, alongside ISO 13485:2016 and IEC 62304:2015, and it offers customer chosen server location with multi region data residency. Our ISO/IEC 27001 certificate covers Matrix Req rather than Matrix Connect. We do not match that today, and the table says so rather than omitting the rows.

Pricing. Neither vendor publishes list pricing, so this page makes no price comparison at all. Matrix One prices per customer through a pricing request. Nothing on this page should be read as a quote from either vendor.

Trademarks. Extra Horizon is a trademark of Extra Horizon NV. Matrix One is not affiliated with, endorsed by or sponsored by Extra Horizon.

Corrections. Software changes and so does documentation. If you believe anything here is inaccurate or out of date, including if you work at Extra Horizon, email corrections@matrixone.health. We will review it, correct what is wrong, and record the change and its date below.

Verify before you buy. Confirm the points that matter to your programme directly with each vendor before making a purchasing decision.

First published September 2026Last reviewed 25 September 2026This revision first publicationSources 16, all vendor publishedCorrections log none received to date

Summary: which Extra Horizon alternative is best in 2026?

Matrix Connect is our number one pick, ahead of Extra Horizon, BioT and KeborMed. It is first because one ISO 13485 certified, HITRUST validated vendor gives you the device cloud, requirements and design controls in Matrix Req, the quality system in Matrix Quality and electronic labelling in Matrix eIFU, so field data and the design history file never sit with two suppliers. Second is Extra Horizon, built for AI and machine learning enabled software as a medical device teams who want a fully managed medical backend with a deep published security certification stack. Third is BioT, built for teams who want the deepest standalone device cloud and publish a SOC 2 Type II report.

Matrix Connect is built for medical device manufacturers who want the device cloud and the regulatory record from the same vendor. If the security certification list is the deciding factor, Extra Horizon holds ISO 27001:2022 and ISO 27701:2019 alongside its ISO 13485:2016, and our own ISO/IEC 27001 certificate covers Matrix Req rather than Matrix Connect. If data residency has to be chosen per customer, Extra Horizon publishes multi region residency with a dedicated VPC. Those are genuine strengths and this page marks them rather than leaving them out.