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Sequenex Alternative

Matrix Connect and Sequenex, compared on published facts

Short answer: the best Sequenex alternative for a connected medical device programme in 2026 is Matrix Connect, ahead of Sequenex, BioT and KeborMed. Matrix Connect is first because it is a product you licence and configure rather than an engineering engagement, and because the device cloud, requirements and design controls, the quality system and electronic labelling come from a single ISO 13485 certified vendor.

Sequenex builds firmware, mobile apps and cloud in one team, which we do not, and it is ahead of us in places. Those places are marked on this page rather than left out. Every statement about Sequenex here comes from Sequenex's own published documentation and links to it.

For taking a demo with our team.

Matrix Connect vs Sequenex, at a glance
Matrix Connect
Sequenex
Requirements and design controls from the same vendor
✓ Matrix Req8Same vendor, same contract
Documentation serviceDHF support, not a product2
Quality management in the same suite
✓ Matrix Quality7CAPA, deviations, training, document control
Not a published moduleNot in the NEX component list2
ISO 13485 held for this product
✓ Certified3Certificate published on the website
✓ Certified QMSDevelopment runs under it2
Licensed product rather than an engineering engagement
✓ Product1Licence and configure
Services modelNo separate NEX licence fee2
Deployment outside a single public cloud
Not published1We do not claim it, so we do not show it
✓ Your own AWS accountSequenex is ahead of us here4

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 Sequenex is ahead, the table says that too.

Matrix Connect
Sequenex
Industry fit
Built only for medical devices and life sciences
YesEvery product in the Matrix One suite serves life sciences only. 1
YesSequenex describes itself as a platform and SaMD product development company for medtech, diabetes and digital health. 5
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 publishedSequenex does not publish a device class scope. Named focus areas are diabetes care, CGM and biosensors, connected wearables and connected drug delivery. 4
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
Not publishedSequenex does not publish regulatory clearances obtained on the NEX platform. 2
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
CertifiedSequenex develops medtech software under an ISO 13485 certified quality management system. 2
HITRUST CSF validated
CertifiedHITRUST CSF r2 validated, and the validation covers Matrix Connect specifically. 3
Not publishedHITRUST does not appear in Sequenex's published compliance list. 2
SOC 2 Type II attestation
Not publishedMatrix One does not publish a SOC 2 Type II attestation. 3
Not publishedSequenex does not publish a SOC 2 Type II attestation. 2
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
Not publishedISO/IEC 27001 does not appear in Sequenex's published compliance list. 2
IEC 62304 software lifecycle
YesDevelopment processes compliant with IEC 62304 and ISO 14971. 6
YesSoftware developed in accordance with IEC 62304 and ISO 14971. 2
HIPAA and GDPR
YesMatrix Connect adheres to HIPAA and complies with GDPR for EU and UK personal data. 6
Compliance statedNEX is “designed to support HIPAA and GDPR requirements”, and 21 CFR Part 11 “where applicable”. 2
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 publishedNEX is configured and integrated by Sequenex engineers rather than through a self service configuration tool. 2
Device SDK and web API
YesNative SDK plus a modular web API for third party systems. 1
YesAPIs, device management and authentication are named NEX components, covering BLE, NFC, WiFi, cellular, third party APIs and cloud to cloud integrations. 2
Remote monitoring with alerts and notifications
YesReal time alerts and notifications with a mobile friendly portal. 1
YesPrebuilt patient and clinician dashboards with real time data, plus an administrator portal. 4
Role based access for clinicians, patients and families
YesRole based access with customisable data visibility for providers, patients and families. 1
YesRole based access control and audit logging in the backend data architecture. 4
Dashboards, analytics and data export
YesConfigurable dashboards and data exports. 1
YesPrebuilt patient and clinician dashboards and an administrator portal for user provisioning and audit access. 4
EHR and EMR integration
YesEHR and EMR connections through standardised APIs. 1
Not publishedEHR or EMR integration is not named in the published NEX component 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
YesNEX is “delivered in your infrastructure”, with the HIPAA ready backend deployed to the customer's own AWS environment. Sequenex is ahead of us on this one. 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 moduleSequenex supplies design history file documentation as part of an engineering engagement rather than a requirements management product. 2
CAPA, deviations, complaints and change control
YesMatrix Quality. 7
Not a published moduleNot listed in the published NEX component set. 2
Training management and controlled documents
YesMatrix Quality. 7
Not a published moduleNot listed in the published NEX component 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 moduleSequenex develops in accordance with ISO 14971, which is not the same as risk management tooling for your device. 2
Electronic instructions for use and labelling
YesMatrix eIFU, from the same vendor. 13
Not a published moduleNot listed in the published NEX component 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 moduleNEX covers the device and cloud layer, so quality records sit with a second vendor. 2
Commercial and company
List pricing published
NoMatrix One quotes per customer through a pricing request rather than publishing tiers. 11
NoSequenex states there is “currently no separate NEX platform licensing fee”, and that customers pay for the engineering services that configure and integrate it. 2
Published build versus buy cost comparison
YesA total cost of ownership calculator comparing Matrix Connect with an in house build. 1
YesSequenex states that building the same components from scratch under IEC 62304 inside an ISO 13485 quality system takes “six to nine months before clinical features even start”. 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
YesSequenex builds firmware, mobile apps and cloud infrastructure in one team, with named focus on diabetes, CGM, biosensors and connected drug delivery. 4
Book a demo →
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
Book a demo →
Sequenex
Industry fit
Built only for medical devices and life sciences
YesSequenex describes itself as a platform and SaMD product development company for medtech, diabetes and digital health. 5
Supports Class III and life sustaining devices
Not publishedSequenex does not publish a device class scope. Named focus areas are diabetes care, CGM and biosensors, connected wearables and connected drug delivery. 4
Customer devices cleared by regulators on the platform
Not publishedSequenex does not publish regulatory clearances obtained on the NEX platform. 2
Compliance and certifications
ISO 13485 held by the vendor for this product
CertifiedSequenex develops medtech software under an ISO 13485 certified quality management system. 2
HITRUST CSF validated
Not publishedHITRUST does not appear in Sequenex's published compliance list. 2
SOC 2 Type II attestation
Not publishedSequenex does not publish a SOC 2 Type II attestation. 2
ISO/IEC 27001 held for this product
Not publishedISO/IEC 27001 does not appear in Sequenex's published compliance list. 2
IEC 62304 software lifecycle
YesSoftware developed in accordance with IEC 62304 and ISO 14971. 2
HIPAA and GDPR
Compliance statedNEX is “designed to support HIPAA and GDPR requirements”, and 21 CFR Part 11 “where applicable”. 2
Platform capability
Configure data models and workflows without writing code
Not publishedNEX is configured and integrated by Sequenex engineers rather than through a self service configuration tool. 2
Device SDK and web API
YesAPIs, device management and authentication are named NEX components, covering BLE, NFC, WiFi, cellular, third party APIs and cloud to cloud integrations. 2
Remote monitoring with alerts and notifications
YesPrebuilt patient and clinician dashboards with real time data, plus an administrator portal. 4
Role based access for clinicians, patients and families
YesRole based access control and audit logging in the backend data architecture. 4
Dashboards, analytics and data export
YesPrebuilt patient and clinician dashboards and an administrator portal for user provisioning and audit access. 4
EHR and EMR integration
Not publishedEHR or EMR integration is not named in the published NEX component list. 2
Deployment outside a single public cloud
YesNEX is “delivered in your infrastructure”, with the HIPAA ready backend deployed to the customer's own AWS environment. Sequenex is ahead of us on this one. 4
Design controls, quality and labelling in the same suite
Requirements management and design controls from the same vendor
Not a published moduleSequenex supplies design history file documentation as part of an engineering engagement rather than a requirements management product. 2
CAPA, deviations, complaints and change control
Not a published moduleNot listed in the published NEX component set. 2
Training management and controlled documents
Not a published moduleNot listed in the published NEX component set. 2
Risk management to ISO 14971 in the same suite
Not a published moduleSequenex develops in accordance with ISO 14971, which is not the same as risk management tooling for your device. 2
Electronic instructions for use and labelling
Not a published moduleNot listed in the published NEX component set. 2
Post market device data linked to quality records under one contract
Not a published moduleNEX covers the device and cloud layer, so quality records sit with a second vendor. 2
Commercial and company
List pricing published
NoSequenex states there is “currently no separate NEX platform licensing fee”, and that customers pay for the engineering services that configure and integrate it. 2
Published build versus buy cost comparison
YesSequenex states that building the same components from scratch under IEC 62304 inside an ISO 13485 quality system takes “six to nine months before clinical features even start”. 4
Track record in medical device cloud connectivity
YesSequenex builds firmware, mobile apps and cloud infrastructure in one team, with named focus on diabetes, CGM, biosensors and connected drug delivery. 4

Sources for this comparison

  1. 1Matrix One, Matrix Connect product page. https://matrixone.health/products/matrix-connect
  2. 2Sequenex, NEX platform page. https://sequenex.com/nex-platform/
  3. 3Matrix One, compliance and certifications, with the certificates published in full. https://matrixone.health/compliance-certifications
  4. 4Sequenex, connected medical device platform development service. https://sequenex.com/services/connected-medical-device-platform-development/
  5. 5Sequenex, medical device software development service. https://sequenex.com/services/medical-device-software-development/
  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

Sequenex is an engineering partner with a platform accelerator rather than a self service product, so several platform rows record what NEX ships as a component against what Matrix Connect ships as configurable product. The distinction matters more than any single row.

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 Sequenex, 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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Full source list

14 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. 2Sequenex, NEX platform page.https://sequenex.com/nex-platform/
  3. 3Matrix One, compliance and certifications, with the certificates published in full.https://matrixone.health/compliance-certifications
  4. 4Sequenex, connected medical device platform development service.https://sequenex.com/services/connected-medical-device-platform-development/
  5. 5Sequenex, medical device software development service.https://sequenex.com/services/medical-device-software-development/
  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

Methodology and corrections

Scope. This page compares Matrix Connect and Sequenex 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 Sequenex are drawn from Sequenex'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 Sequenex is ahead. Sequenex states there is no separate NEX platform licensing fee, deploys the backend into the customer’s own AWS environment, and covers embedded firmware and native mobile app development, which Matrix Connect does not. We do not match those today, and the table says so rather than omitting the rows.

Pricing. Sequenex states there is "currently no separate NEX platform licensing fee" and that customers pay for the engineering services that configure and integrate it, so the two commercial models are not directly comparable. Matrix One prices per customer through a pricing request. Nothing on this page should be read as a quote from either vendor.

Trademarks. Sequenex and NEX are trademarks of Sequenex LLC. Matrix One is not affiliated with, endorsed by or sponsored by Sequenex.

Corrections. Software changes and so does documentation. If you believe anything here is inaccurate or out of date, including if you work at Sequenex, 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 14, all vendor publishedCorrections log none received to date

Summary: which Sequenex alternative is best in 2026?

Matrix Connect is our number one pick, ahead of Sequenex, 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 Sequenex, built for diabetes, CGM, biosensor and connected drug delivery programmes that want firmware, mobile and cloud engineering from one partner. 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 programme still needs embedded firmware, a native mobile app and human factors validated UX built alongside the cloud, Sequenex does all of that in one team and Matrix Connect does not. If the backend has to sit inside your own AWS account, Sequenex deploys it there. Those are genuine strengths and this page marks them rather than leaving them out.

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