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BioT Alternative

Matrix Connect and BioT, compared on published facts

Short answer: the best BioT alternative for a connected medical device programme in 2026 is Matrix Connect, ahead of BioT, BrightInsight and Orthogonal. 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.

BioT is a strong platform and it is ahead of us in places. Those places are marked on this page rather than left out. Every statement about BioT here comes from BioT's own published documentation and links to it.

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Matrix Connect vs BioT, at a glance
Matrix Connect
BioT
Requirements and design controls from the same vendor
✓ Matrix Req9Same vendor, same contract
Partner integrationOrcanos, announced December 202510
Quality management in the same suite
✓ Matrix Quality8CAPA, deviations, training, document control
Partner integrationNot a published BioT module10
ISO 13485 held for this product
✓ Certified3Certificate published on the website
✓ ListedCertificates available on request5
HITRUST CSF validated
✓ r2 validated3Covers Matrix Connect
✓ r2 certifiedv11.4.1 r25
SOC 2 Type II attestation
Not published3We do not claim it, so we do not show it
✓ AttestedBioT is ahead of us here5

Compiled from information published by each vendor and checked on 11 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 coversA 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 startEvery 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 itPatient 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 volumeEntry 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 submissionDesign 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 outGetting 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
Our solution

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

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

  • Building the cloud yourself costs more than the estimate

  • A 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.

  • A device cloud you configure instead of build

  • Model 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.

  • Security evidence arrives late and holds up the submission

  • Cybersecurity 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.

  • Certification you inherit

  • Matrix 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.

  • The device cloud and the quality system never quite meet

  • Complaints, 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.

  • Post market data that lands next to your quality records

  • Matrix 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.

  • Pilot architecture does not survive commercial volume

  • What 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.

  • Design controls in the same suite

  • Matrix 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.

  • Every new market adds another set of rules

  • FDA, 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.

  • Built for Class III as well as wellness

  • Matrix Connect already supports Class III implantable and life sustaining devices in production, including LVADs, neurostimulators and cardiac monitoring.

  • The connectivity team you need is hard to hire

  • Cloud engineers who also understand IEC 62304, ISO 14971 and HIPAA are scarce, expensive and usually already employed.

  • Clearances our customers already hold

  • Customers 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.

    The challenge

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

  • Building the cloud yourself costs more than the estimate

  • A 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 submission

  • Cybersecurity 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 meet

  • Complaints, 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 volume

  • What 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 rules

  • FDA, 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 hire

  • Cloud 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 build

  • Model 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 inherit

  • Matrix 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 records

  • Matrix 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 suite

  • Matrix 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 wellness

  • Matrix Connect already supports Class III implantable and life sustaining devices in production, including LVADs, neurostimulators and cardiac monitoring.

  • Clearances our customers already hold

  • Customers 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." [13]
    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. [16]

    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 BioT is ahead, the table says that too.

    Matrix Connect
    BioT
    Industry fit
    Built only for medical devices and life sciences
    YesEvery product in the Matrix One suite serves life sciences only. 1
    YesBioT describes itself as the infrastructure for medical device clouds. 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. 11
    Yes"BioT supports all device classifications, including Class III." 6
    Customer devices cleared by regulators on the platform
    YesCustomers have obtained FDA clearance, CE Mark, EU MDR, IVDR, Health Canada and Australian TGA approvals. 7
    YesBioT states customers have achieved FDA clearance and CE marking on 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 appears in BioT's published certification list. Certification documents are offered on request rather than published. 5
    HITRUST CSF validated
    CertifiedHITRUST CSF r2 validated, and the validation covers Matrix Connect specifically. 3
    Certified"HITRUST CSF Certified (v11.4.1 r2)". 5
    SOC 2 Type II attestation
    Not publishedMatrix One does not publish a SOC 2 Type II attestation. BioT is ahead of us on this one. 3
    YesSOC 2 Type II covering security, availability, confidentiality and privacy. 5
    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 and ISO 27799 certified. 5
    IEC 62304 software lifecycle
    YesDevelopment processes compliant with IEC 62304 and ISO 14971. 7
    YesIEC 62304 followed, with a design history file and an SBOM per release. 4
    HIPAA and GDPR
    YesMatrix Connect adheres to HIPAA and complies with GDPR for EU and UK personal data. 7
    YesHIPAA and GDPR frameworks, with BAAs and DPAs executed. 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
    Yes"Configure data models, workflows, and analytics effortlessly with no/low code" in Developer Studio. 2
    Device SDK and web API
    YesNative SDK plus a modular web API for third party systems. 1
    YesDevice SDKs with REST and MQTT documentation, plus full API access. 6
    Remote monitoring with alerts and notifications
    YesReal time alerts and notifications with a mobile friendly portal. 1
    YesRemote patient monitoring is a named service in the Cloud Services Library. 2
    Role based access for clinicians, patients and families
    YesRole based access with customisable data visibility for providers, patients and families. 1
    YesAttribute based access control down to the data attribute level. 6
    Dashboards, analytics and data export
    YesConfigurable dashboards and data exports. 1
    YesRegulatory aware analytics and an operational portal. 2
    EHR and EMR integration
    YesEHR and EMR connections through standardised APIs. 1
    YesEHR integration with FHIR and HL7. 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
    YesBioT states it can deploy on premise or adapt to other cloud providers. 6
    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. 9
    Not a published moduleBioT announced a partnership with Orcanos in December 2025 to connect its cloud with eQMS and design control software. It is a partner product, not a BioT module. 10
    CAPA, deviations, complaints and change control
    YesMatrix Quality. 8
    Not a published moduleAvailable through the Orcanos partnership rather than as a BioT module. 10
    Training management and controlled documents
    YesMatrix Quality. 8
    Not a published moduleAvailable through the Orcanos partnership rather than as a BioT module. 10
    Risk management to ISO 14971 in the same suite
    YesMatrix Req covers hazard analysis and risk to ISO 14971. 9
    Not a published moduleRisk management tooling is not listed in BioT's own feature set. 2
    Electronic instructions for use and labelling
    YesMatrix eIFU, from the same vendor. 18
    Not a published moduleNot listed in BioT's own feature 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. 8
    DiffersPossible through the BioT and Orcanos integration, which means two vendors and two agreements. 10
    Commercial and company
    List pricing published
    NoMatrix One quotes per customer through a pricing request rather than publishing tiers. 15
    YesFour editions published on AWS Marketplace, from $1,500 to $7,500 per month, with no upfront licence fees and AWS infrastructure billed separately. Checked 11 September 2026. 6
    Published build versus buy cost comparison
    YesA total cost of ownership calculator comparing Matrix Connect with an in house build. 1
    YesA three year comparison putting an in house build at $2,288,875 against $438,100 on BioT. 14
    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. 17
    YesBioT was founded in 2018 and has offices in Tel Aviv, Boston and Hannover. 12
    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. 11
    Customer devices cleared by regulators on the platform
    YesCustomers have obtained FDA clearance, CE Mark, EU MDR, IVDR, Health Canada and Australian TGA approvals. 7
    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. BioT is ahead of us on this one. 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. 7
    HIPAA and GDPR
    YesMatrix Connect adheres to HIPAA and complies with GDPR for EU and UK personal data. 7
    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. 9
    CAPA, deviations, complaints and change control
    YesMatrix Quality. 8
    Training management and controlled documents
    YesMatrix Quality. 8
    Risk management to ISO 14971 in the same suite
    YesMatrix Req covers hazard analysis and risk to ISO 14971. 9
    Electronic instructions for use and labelling
    YesMatrix eIFU, from the same vendor. 18
    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. 8
    Commercial and company
    List pricing published
    NoMatrix One quotes per customer through a pricing request rather than publishing tiers. 15
    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. 17
    BioT
    Industry fit
    Built only for medical devices and life sciences
    YesBioT describes itself as the infrastructure for medical device clouds. 2
    Supports Class III and life sustaining devices
    Yes"BioT supports all device classifications, including Class III." 6
    Customer devices cleared by regulators on the platform
    YesBioT states customers have achieved FDA clearance and CE marking on the platform. 4
    Compliance and certifications
    ISO 13485 held by the vendor for this product
    CertifiedISO 13485 appears in BioT's published certification list. Certification documents are offered on request rather than published. 5
    HITRUST CSF validated
    Certified"HITRUST CSF Certified (v11.4.1 r2)". 5
    SOC 2 Type II attestation
    YesSOC 2 Type II covering security, availability, confidentiality and privacy. 5
    ISO/IEC 27001 held for this product
    YesISO 27001 and ISO 27799 certified. 5
    IEC 62304 software lifecycle
    YesIEC 62304 followed, with a design history file and an SBOM per release. 4
    HIPAA and GDPR
    YesHIPAA and GDPR frameworks, with BAAs and DPAs executed. 4
    Platform capability
    Configure data models and workflows without writing code
    Yes"Configure data models, workflows, and analytics effortlessly with no/low code" in Developer Studio. 2
    Device SDK and web API
    YesDevice SDKs with REST and MQTT documentation, plus full API access. 6
    Remote monitoring with alerts and notifications
    YesRemote patient monitoring is a named service in the Cloud Services Library. 2
    Role based access for clinicians, patients and families
    YesAttribute based access control down to the data attribute level. 6
    Dashboards, analytics and data export
    YesRegulatory aware analytics and an operational portal. 2
    EHR and EMR integration
    YesEHR integration with FHIR and HL7. 2
    Deployment outside a single public cloud
    YesBioT states it can deploy on premise or adapt to other cloud providers. 6
    Design controls, quality and labelling in the same suite
    Requirements management and design controls from the same vendor
    Not a published moduleBioT announced a partnership with Orcanos in December 2025 to connect its cloud with eQMS and design control software. It is a partner product, not a BioT module. 10
    CAPA, deviations, complaints and change control
    Not a published moduleAvailable through the Orcanos partnership rather than as a BioT module. 10
    Training management and controlled documents
    Not a published moduleAvailable through the Orcanos partnership rather than as a BioT module. 10
    Risk management to ISO 14971 in the same suite
    Not a published moduleRisk management tooling is not listed in BioT's own feature set. 2
    Electronic instructions for use and labelling
    Not a published moduleNot listed in BioT's own feature set. 2
    Post market device data linked to quality records under one contract
    DiffersPossible through the BioT and Orcanos integration, which means two vendors and two agreements. 10
    Commercial and company
    List pricing published
    YesFour editions published on AWS Marketplace, from $1,500 to $7,500 per month, with no upfront licence fees and AWS infrastructure billed separately. Checked 11 September 2026. 6
    Published build versus buy cost comparison
    YesA three year comparison putting an in house build at $2,288,875 against $438,100 on BioT. 14
    Track record in medical device cloud connectivity
    YesBioT was founded in 2018 and has offices in Tel Aviv, Boston and Hannover. 12

    Sources for this comparison

    1. 1Matrix One, Matrix Connect product page. https://matrixone.health/products/matrix-connect
    2. 2BioT, platform and product page. https://www.biot-med.com/product
    3. 3Matrix One, compliance and certifications, with the certificates published in full. https://matrixone.health/compliance-certifications
    4. 4BioT, medical device cloud compliance page, including its shared responsibility model. https://www.biot-med.com/compliance
    5. 5BioT documentation, certifications and validations. https://docs.biot-med.com/docs/other-certifications-and-validations
    6. 6BioT, frequently asked questions, including published edition pricing. https://www.biot-med.com/faq
    7. 7Matrix One, Matrix Connect compliant cloud platform. https://matrixone.health/connect/compliant-cloud-platform
    8. 8Matrix One, Matrix Quality product page. https://matrixone.health/products/matrix-quality
    9. 9Matrix One, Matrix Req product page. https://matrixone.health/products/matrix-req
    10. 10BioT and Orcanos partnership announcement, 21 December 2025. https://www.biot-med.com/resources/biot-and-orcanos-announce-strategic-partnership-to-connect-medical-device-cloud-with-eqms-and-alm
    11. 11Matrix One, Matrix Connect for Class III connected devices. https://matrixone.health/connect/class-iii-connected-devices
    12. 12BioT, about the company. https://www.biot-med.com/about
    13. 13Matrix One, Alimetry customer story. https://matrixone.health/customer-success-stories/-matrix-connect-alimetry-case-study
    14. 14BioT, build versus buy three year cost comparison. https://www.biot-med.com/resources/build-vs-buy-medical-device-cloud-platform-cost-comparison
    15. 15Matrix One, pricing request page. https://matrixone.health/get-pricing
    16. 16Matrix One, Matrix Connect scalability and uptime. https://matrixone.health/connect/scalability-and-uptime
    17. 17Matrix One, about us and company timeline. https://matrixone.health/about-us
    18. 18Matrix One, Matrix eIFU product page. https://matrixone.health/products/matrix-eifu

    "Via a partner" describes what BioT publishes, which is an integration with Orcanos announced in December 2025. BioT is configurable, so a customer could hold quality records elsewhere and connect them. The distinction we draw is between capability bought from one vendor under one contract and capability assembled from two.

    This comparison is compiled from information published by each vendor and was checked on 11 September 2026. It does not cover support responsiveness, implementation duration, ease of use or system performance, because those cannot be established as fact about another vendor's product from the outside. Pricing is reported only where a vendor publishes it. Software changes, so verify the points that matter to your programme directly with each vendor.

    Moving off BioT, 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
    Book your migration assessment
    Free 30-min session
    No credit card
    No spam, ever

    Thank you

    A member of our team will be in contact within 48 hours.

    Full source list

    Eighteen sources, all vendor published and reachable without a login. Checked 11 September 2026.

    1. 1Matrix One, Matrix Connect product page.https://matrixone.health/products/matrix-connect
    2. 2BioT, platform and product page.https://www.biot-med.com/product
    3. 3Matrix One, compliance and certifications, with the certificates published in full.https://matrixone.health/compliance-certifications
    4. 4BioT, medical device cloud compliance page, including its shared responsibility model.https://www.biot-med.com/compliance
    5. 5BioT documentation, certifications and validations.https://docs.biot-med.com/docs/other-certifications-and-validations
    6. 6BioT, frequently asked questions, including published edition pricing.https://www.biot-med.com/faq
    7. 7Matrix One, Matrix Connect compliant cloud platform.https://matrixone.health/connect/compliant-cloud-platform
    8. 8Matrix One, Matrix Quality product page.https://matrixone.health/products/matrix-quality
    9. 9Matrix One, Matrix Req product page.https://matrixone.health/products/matrix-req
    10. 10BioT and Orcanos partnership announcement, 21 December 2025.https://www.biot-med.com/resources/biot-and-orcanos-announce-strategic-partnership-to-connect-medical-device-cloud-with-eqms-and-alm
    11. 11Matrix One, Matrix Connect for Class III connected devices.https://matrixone.health/connect/class-iii-connected-devices
    12. 12BioT, about the company.https://www.biot-med.com/about
    13. 13Matrix One, Alimetry customer story.https://matrixone.health/customer-success-stories/-matrix-connect-alimetry-case-study
    14. 14BioT, build versus buy three year cost comparison.https://www.biot-med.com/resources/build-vs-buy-medical-device-cloud-platform-cost-comparison
    15. 15Matrix One, pricing request page.https://matrixone.health/get-pricing
    16. 16Matrix One, Matrix Connect scalability and uptime.https://matrixone.health/connect/scalability-and-uptime
    17. 17Matrix One, about us and company timeline.https://matrixone.health/about-us
    18. 18Matrix One, Matrix eIFU product page.https://matrixone.health/products/matrix-eifu

    Methodology and corrections

    Scope. This page compares Matrix Connect and BioT 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 BioT are drawn from BioT's own website, documentation and support pages, 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 the basis for any factual statement on this page.

    Where BioT is ahead. BioT publishes a SOC 2 Type II attestation and ISO 27001 and ISO 27799 certification, it publishes list pricing, and it offers deployment outside a single public cloud. We do not match those today, and the table says so rather than omitting the rows.

    Pricing. BioT's edition prices are taken from BioT's own published list and were checked on 11 September 2026. Matrix One prices per customer, so there is no list to compare against. Nothing on this page should be read as a quote from either vendor.

    Trademarks. BioT and BioT Medical are trademarks of BioT Medical Ltd. Orcanos is a trademark of Orcanos Ltd. Matrix One is not affiliated with, endorsed by or sponsored by either company.

    Corrections. Software changes and so does documentation. If you believe anything here is inaccurate or out of date, including if you work at BioT, 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 11 September 2026This revision first publicationSources 18, all vendor publishedCorrections log none received to date

    Summary: which BioT alternative is best in 2026?

    Matrix Connect is our number one pick, ahead of BioT, BrightInsight and Orthogonal. 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 BioT, the strongest standalone device cloud and the better answer if SOC 2 Type II, ISO 27001 or deployment outside a single public cloud is a hard requirement. Third is BrightInsight for large pharma and device enterprises.

    Do not buy Matrix Connect if you need a SOC 2 Type II report in the contract, if you need to run the platform on your own infrastructure, or if you only want a cloud and already have a quality system you are happy with. In that last case the suite is the reason to choose us, and you would not be using it.