Sold by: BioT Medical
Deployed on AWS
BioT is a certified cloud platform (PaaS) for connected medical devices: device connectivity, clinical data management, analytics, and patient and clinician portals with FDA, HIPAA, GDPR, and MDR compliance built in. ISO27001, HITRUST r2 and SOC 2 Type II certified. Pilots launch in weeks.
Overview
BioT is the infrastructure for medical device clouds: a validated, patented Platform as a Service (PaaS) that medical device manufacturers use to connect devices, manage real-time clinical data, run analytics, and deliver connected care applications without building cloud infrastructure from scratch.
Compliance is inherited, not built. BioT holds HITRUST r2 certification and SOC 2 Type II attestation, and is ISO 13485, ISO 27001, and ISO 27799 certified. The platform is compliant with HIPAA, GDPR, FDA 21 CFR Part 11, and MDR/IVDR, with software development under IEC 62304. Building equivalent compliance in-house typically takes 12-24 months and $945K in direct certification costs before US health systems will advance procurement.
The platform is built for MedTech workflows out of the box: device lifecycle management with OTA updates, patient and caregiver management, remote monitoring, alert rules, regulatory-aware analytics, and native PHI protection with attribute-based access control (ABAC). Devices connect over MQTT and REST; most device onboarding completes in under a day. The Developer Studio supports no-code configuration, low-code rules, and full pro-code APIs, with EHR, EDC, and third-party algorithm integration built in.
BioT supports single-tenant and multi-tenant deployment models with full data isolation, deployed on AWS with multi-region availability in the US, EU, and Asia. The platform runs on your cloud account: you own and control all data at all times.
BioT powers over 100,000 devices for MedTech companies across cardiology, neurology, respiratory care, maternal health, and aesthetics, supporting CE-marked and FDA-cleared solutions from Class I through Class III. Customers report reaching certification and revenue 18-24 months sooner and cutting three-year cloud operating expenses by 80 percent versus building in-house.
Highlights
- Inherited compliance from day one: HITRUST r2, SOC 2 Type II, ISO 13485/27001/27799, HIPAA, GDPR, FDA 21 CFR Part 11, and MDR/IVDR. Skip the 18-24 month certification wait and an estimated $945K in direct certification costs.
- Weeks to pilot, not months: no-code device templates, patient and clinician modules, and device onboarding in under a day. Full production deployments typically run 2 to 4 months.
- Open and interoperable: MQTT and REST device connectivity, native EHR/EDC integration, plugin API for your own algorithms and AI models, and single-tenant or multi-tenant deployment on AWS in the US, EU, and Asia.
Details
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Pricing
Pricing is based on the duration and terms of your contract with the vendor. This entitles you to a specified quantity of use for the contract duration. If you choose not to renew or replace your contract before it ends, access to these entitlements will expire.
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Dimension | Description | Cost/month |
|---|---|---|
Start Edition | Up to 5 devices under fair usage | $1,500.00 |
Development Edition | Includes a single development deployment. | $2,950.00 |
Study Edition | Includes with separated development and production deployments for clinical trials and studies. | $4,150.00 |
Essentials Edition | Includes 2 development deployments, and 1 high availability production deployment. | $7,500.00 |
Dimensions summary
You choose one of four editions, each sold as a contract based on deployment scope. Start Edition covers up to 5 devices under fair usage, suited to early evaluation. Development Edition includes a single development deployment. Study Edition separates development from production deployments, aimed at clinical trials and studies. Essentials Edition includes 2 development deployments plus 1 high-availability production deployment. Pricing scales with the number and type of deployments you need, moving from a limited device count, to development-only, to combined development and production environments.
Top-of-mind questions for buyers
The Start Edition covers up to 5 connected devices under fair usage. A device can be hardware, software as a medical device (SaMD), or an AI-based medical device that connects to the platform. This edition suits early evaluation before you scale to production deployments.
A development deployment is an environment for building and configuring your solution. A production deployment runs your live, connected service. Study Edition separates the two for clinical trials. Essentials Edition adds a high-availability production deployment, meaning the production environment is built to stay running through failures.
Pricing follows deployment scope, not per-device metering beyond the Start Edition limit. Start Edition caps device count. Development Edition gives one build environment. Study Edition adds a separated production environment. Essentials Edition adds two development deployments plus one high-availability production deployment. You select the edition matching your current phase.
docs.biot-med.com
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Delivery details
Software as a Service (SaaS)
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Vendor support
For Support contact: support@biot-med.com | For any additional Platform or Pricing questions contact: info@biot-med.com .
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BioT Development Platform enables companies to easily integrate any medical device during their development stages.
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