SynapseMD - iRevolution

The connected platform to speed up certification and the deployment of medical devices

Synapse.MD is a SaaS platform designed for manufacturers of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD).

The Challenge

Developing a medical device without complicating its regulatory process.

Today, manufacturers must simultaneously manage:

● increasing regulatory requirements under the MDR and IVDR;

● frequent changes to software and user flows;

● data exchanges with patients, healthcare professionals, and laboratories;

● heterogeneous IT environments that are difficult to integrate.

Our Approach

Decouple the medical core from its operational ecosystem.

Synapse.MD is built on a modular architecture that isolates your regulated medical functionality

from the interaction and connectivity layer.

The platform isolates your regulated medical logic (DM Engine) within a restricted scope, separate from the connectivity layer (DM Access Point) and the application ecosystem—without completely removing these elements from the scope of the MDR/IVDR, but significantly reducing the scope subject to reevaluation by the notified body.

The result: you can evolve your ecosystem more quickly, while maintaining control over your regulatory scope.

DM engine

Your proprietary medical logic remains isolated in a controlled environment, with a
clearly defined scope of functionality.

DM access point

The connectivity layer orchestrates users, data, workflows, and integrations with your healthcare environment.

This allows you to evolve your interfaces, user flows, and connectors independently of your core medical system, when permitted by applicable regulations.

A Connected Ecosystem
ready for deployment

Patient App

Pre-consultation data collection, e-consent, and tracking the patient journey.

Pro App

Access to relevant data, reduction in manual data entry, and integration of recommendations generated by the system.

Collection center

Eligibility management, sample preparation, and sample traceability.

Lab Link

Connection to laboratory systems and automation of data and results exchange.

Compliance and Security

Synapse.MD incorporates, from the design phase, the security, traceability, and interoperability requirements necessary for healthcare environments.

● Hosting and processing of health data in accordance with applicable requirements

● GDPR

● HL7 / FHIR

● Traceability and audit trail

● Security controls and regular testing

● Support for applicable quality and regulatory environments

The value for manufacturers

Reduce regulatory complexity.
Control the scope of your system and its changes.

Accelerate your deployments.
Evolve your digital ecosystem without systematically
disrupting your medical core.

Connect your device to the healthcare ecosystem.
Patients, healthcare professionals, specimen collection centers, and laboratories
within a unified architecture.

Prepare for your scale-up.
An infrastructure designed to support multi-country,
multi-stakeholder, and multi-system deployment.

Your medical algorithm is at the heart of your intellectual property.
Synapse.MD connects it to the healthcare ecosystem—with complete security,
in compliance with regulations, and at scale.