End-to-End Connectivity for Every Stage of Innovation

Experience a plug-and-play connectivity platform built for regulated MedTech and Digital Pharma solutions. Fast-track development, ensure regulatory compliance, and eliminate unnecessary hassles - from prototype to full-scale production.
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Please fill out the form below to request an invitation to our BETA Self-Serve POC Tier.
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BETA version currently limited to the US only
1
A New Era

Self-Serve POC Tier –
Ignite Your Innovation

1

Kickstart your proof-of-concept with a ready-to-use, plug-and-play connectivity platform. Ideal for students, medical researchers, emerging healthcare startups, and skunkworks initiatives within large organizations, this tier reduces complexity and accelerates integration. Supercharging your POC innovation is as easy as plug-n-play.

Immediate
Connectivity

Connect your project in minutes
without a steep learning curve.

Cost-Free
Access

Accelerate your innovation journey
without straining your resources.
Regulatory Readiness
from the Start

From POC to production, ensure your solution is on track for regulatory approval from day one.

Smooth
Transitions

Effortlessly scale your
solution as it evolves.

Built-in
Compliance

Align with regulatory
requirements from the outset.

Reliable Data
Continuity

Avoid data loss
during transitions.
Innovate easier
Connect smarter

Focus on your innovation while we handle the connectivity, at no cost to you.

Self-serve access

Tools and guidance to independently connect the POC, ensuring full project control.

Reasonable data limits

Clear, manageable resource allocation designed to support the POC without overburdening it.

Ready-to-use clients

Jump straight into development through user-friendly, pre-built web and mobile clients.

Streamlined Core Features

Curated set of fundamental tools, bypassing the need for custom extensions.
2
Evolve Your Concept

Evolve Your Concept:
The Prototype Tier

2

Transition from POC to a mature prototype with increased customization, higher data capacity, and managed services designed to support growth.

Features:

Customizable Clients:

Customize the web and mobile
interfaces to match your
project’s unique needs.

Dynamic Data Limits:

Adapt flexibly to
your data requirements,
ensuring seamless scaling.

Custom Extensions:

Enhance capabilities with
tailored extensions for
added functionality.

Managed Service:

Focus on core development
while managed services
handle intricate details.
Building Blocks
for Clinical and Market Success

Ensure regulatory alignment from the start, paving the way for seamless transitions - from prototype to full-scale development, clinical trials, and market entry.

ISO-Conscious Development

Enjoy full support for ISO 13485, ISO 27001, IEC 62304, and ISO 14971 during the prototype phase, establishing robust quality, software, and risk management compliance.

Clinical Trial Preparation

Access a comprehensive suite of features that lay the groundwork for clinical trials, ensuring precise monitoring and effective data management.
3
Ready for the Real World

Ready for the Real World:
The MVP Tier

3

Prepare your project for market launch with tools designed for real-world application. Handle sensitive data securely, establish quality agreements, and benefit from comprehensive monitoring and product support.


Key Features:

Sensitive Data Handling:

Robust security protocols to
safely manage sensitive data.

Quality Agreements:

Ensure proper communication and change
controls for regulatory compliance.

Dedicated Instance:

Gain enhanced control and customization
with a dedicated instance.

Monitoring and Product Support:

Stay on track with active monitoring
and exceptional product support.

Pave the Way for Clinical Trials & Full-Scale Deployment

The MVP Tier serves as a critical bridge between prototype development and market launch. By emphasizing essential compliance and real-world readiness, this tier empowers your project to meet the industry's rigorous standards and regulatory expectations.

Clinical Trials and DV Testing Support

Align with vital standards to support clinical trials and DV testing, ensuring your project is well-positioned for regulatory approval and successful real-world application.

Post-Approval Launch Planning from the Start

Prepare for a seamless transition from regulatory approval to market launch with features tailored for post-approval success. This proactive planning sets the stage for sustainable market entry and ongoing growth.

Regulatory Readiness for FDA Evaluation

Achieve robust compliance by aligning with ISO 13485, ISO 27001, IEC 62304, and ISO 14971 standards, ensuring your device is thoroughly prepared for FDA evaluation.

Integrated Compliance and Deployment

Benefit from comprehensive documentation support, secure data handling, and full cybersecurity controls. This integrated approach ensures regulatory compliance and facilitates a swift, smooth market entry.
4
Full-Scale Excellence

Full-Scale Excellence:
The Production Tier

4

Transition to full-scale production with a solution tailored for refinement and scalability. Benefit from custom configurations and a robust infrastructure designed to meet your unique project requirements.

What to expect

Bespoke Configurations:

Tailored features and settings
for optimal performance.

Scalable Data Framework:

A robust infrastructure that
grows with your data needs

Enhanced Security Protocols:

Advanced security measures for
safeguarding sensitive data.

Premium Product Support:

Proactive monitoring and
comprehensive managed services.
Seamless Transition:
FDA Approval to Market

Position yourself ahead of the curve by entering or migrating to the Production Tier as you approach your FDA/CE submission. At this pivotal stage, the platform provides all necessary components for regulatory compliance, secure connectivity, and thorough documentation. As you transition to post-market activities, benefit from dedicated support and maintenance to ensure continued compliance and smooth device operations in a competitive commercial landscape.

FDA Submission Documentation

Leverage an ISO 13485, IEC 62304, and ISO 14971 compliant Core Master File (MAF) on file with the FDA, reducing your submission burden.

Cybersecurity-Centric Architecture

Benefit from an ISO 27001 certified platform designed in full compliance with the latest FDA cybersecurity guidance, ensuring a streamlined approval process and a robust post-market cybersecurity position.

Commercial Growth & Partnerships

Take advantage of integrated Business Associate Agreements (BAAs) management, including electronic signatures and fully managed third-party APIs, to facilitate seamless integrations and collaborations with healthcare providers.

Post-Approval Support

Rely on a globally scalable infrastructure that provides ongoing management, support, and advancement of your MedTech solution, ensuring continued regulatory adherence and operational efficiency after market launch.

Modular Architecture for Continuous Innovation

A flexible, scalable design allows new features to be added as needed, ensuring connectivity always meets the latest industry standards.

Core Capabilities

SECURITY CONTROLS
Enhance protection with isolated and manageable security measures, reducing risk and improving visibility.
COMMUNICATION INFRASTRUCTURE
Enable seamless collaboration with real-time notifications, alerts, and video conferencing.
DATA MANAGEMENT
Ensure accurate, secure data handling with flexible, scalable storage and access control.
PRESENTATION LAYER
Benefit from a user-friendly interface for real-time data access and system management across multiple portals.
FLEET MANAGEMENT
Manage connected devices with real-time tracking, maintenance scheduling, and performance monitoring.

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