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.
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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
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.
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.
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.
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.
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.
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.
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.
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.
Sources for this comparison
- 1Matrix One, Matrix Connect product page. https://matrixone.health/products/matrix-connect
- 2Extra Horizon, medical backend as a service platform. https://extrahorizon.com/platform/medical-baas
- 3Matrix One, compliance and certifications, with the certificates published in full. https://matrixone.health/compliance-certifications
- 4Extra Horizon, frequently asked questions, including its certification list and hosting model. https://extrahorizon.com/faq
- 5Extra Horizon, ISO 13485:2016 certification announcement, 18 March 2021. https://extrahorizon.com/blog/iso-13485-certification-mdr-ivdr
- 6Matrix One, Matrix Connect compliant cloud platform. https://matrixone.health/connect/compliant-cloud-platform
- 7Matrix One, Matrix Quality product page. https://matrixone.health/products/matrix-quality
- 8Matrix One, Matrix Req product page. https://matrixone.health/products/matrix-req
- 9Matrix One, Matrix Connect for Class III connected devices. https://matrixone.health/connect/class-iii-connected-devices
- 10Matrix One, Alimetry customer story. https://matrixone.health/customer-success-stories/-matrix-connect-alimetry-case-study
- 11Matrix One, pricing request page. https://matrixone.health/get-pricing
- 12Matrix One, about us and company timeline. https://matrixone.health/about-us
- 13Matrix One, Matrix eIFU product page. https://matrixone.health/products/matrix-eifu
- 14Matrix One, Matrix Connect scalability and uptime. https://matrixone.health/connect/scalability-and-uptime
- 15Extra Horizon, platform architecture. https://extrahorizon.com/platform/architecture/
- 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 map your device data model, your integrations and your regulatory evidence onto Matrix Connect.
Device records, telemetry history and user accounts moved across with the audit trail intact.
Native SDK or web API, roles and dashboards configured, with the documentation your quality system needs.
Full onboarding with a dedicated Customer Success Manager who knows regulated devices.
Thank you
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.
- 1Matrix One, Matrix Connect product page.https://matrixone.health/products/matrix-connect
- 2Extra Horizon, medical backend as a service platform.https://extrahorizon.com/platform/medical-baas
- 3Matrix One, compliance and certifications, with the certificates published in full.https://matrixone.health/compliance-certifications
- 4Extra Horizon, frequently asked questions, including its certification list and hosting model.https://extrahorizon.com/faq
- 5Extra Horizon, ISO 13485:2016 certification announcement, 18 March 2021.https://extrahorizon.com/blog/iso-13485-certification-mdr-ivdr
- 6Matrix One, Matrix Connect compliant cloud platform.https://matrixone.health/connect/compliant-cloud-platform
- 7Matrix One, Matrix Quality product page.https://matrixone.health/products/matrix-quality
- 8Matrix One, Matrix Req product page.https://matrixone.health/products/matrix-req
- 9Matrix One, Matrix Connect for Class III connected devices.https://matrixone.health/connect/class-iii-connected-devices
- 10Matrix One, Alimetry customer story.https://matrixone.health/customer-success-stories/-matrix-connect-alimetry-case-study
- 11Matrix One, pricing request page.https://matrixone.health/get-pricing
- 12Matrix One, about us and company timeline.https://matrixone.health/about-us
- 13Matrix One, Matrix eIFU product page.https://matrixone.health/products/matrix-eifu
- 14Matrix One, Matrix Connect scalability and uptime.https://matrixone.health/connect/scalability-and-uptime
- 15Extra Horizon, platform architecture.https://extrahorizon.com/platform/architecture/
- 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.
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.