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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Deployed on AWS
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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 |
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Delivery details
Software as a Service (SaaS)
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Support
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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Similar products
BioT Development Platform enables companies to easily integrate any medical device during their development stages.
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