Digital Health
Software Solutions and Interfaces

Anticipate challenges and structure the development of your digital innovation

➜ Strategic and operational consulting

We help you structure your project by offering strategic and operational support :

• Product consulting : assistance in defining the type of digital medical device and its positioning.
• Software-specific documentation consulting : integration of software requirements into your quality management system and technical documentation.
• Consulting on associated tele-services : development of connected, compliant, and efficient solutions.

➜ Project management and AMOA support

We provide assistance to project ownership (AMOA) to oversee the development of your digital products in collaboration with digital services companies (ESNs).

• Implementation of best practices for development and design to anticipate the compliance of your product.

Designing Intuitive, Functional, and User-Friendly Products

➜ Functional analysis and user-centered design

• Functional analysis : in-depth exploration of functional needs to align your product with user expectations and regulatory requirements.
• UI/UX design :
  User-centered design methodology tailored to medical devices.
  Product design and product management adapted to the specificities of the digital health sector.

➜ UX audit, prototyping, and user experience

• UX audits and analysis :
  Preliminary UX audit report.
  Comparative analysis of competitor user interfaces.
  User interviews and creation/documentation of personas for a needs-centered approach.
• Prototyping :
  Development of low-fidelity (lo-fi) and high-fidelity (hi-fi) prototypes to test and validate interfaces.
  Integration of the design into your solution to ensure visual and functional consistency.

➜ User experience

• Usability study : Conducting tests and delivering a comprehensive test report covering all user-expressed needs.
• Design System : Creating branding elements, icons, typography, color palettes, and interaction models to ensure visual consistency and intuitive navigation across all interfaces and products.

➜ Usability testing

These tests are recommended for digital devices and for mechanical or biological devices as part of the compliance process. They provide a solid foundation for creating the technical documentation required for CE marking.

• Formative tests : analysis of your product's characteristics in response to specific user needs (under real-world conditions).
  
• Summative tests : global evaluation of usability and risk identification to enable continuous improvement.

Ensure the performance and compliance of your device

➜ Creating technical documentation

Aligned with European regulations 2017/745 (MDR) and 2017/746 (IVDR) :

• Expertise and complete drafting or support for documentation creation.
• Compliance with ISO 62304 and 82304 standards.
• Software tool audits (VSI audit).

➜ Preparation of technical documentation under the AI Act

Risk management and compliance with performance and safety requirements.

➜ Implementation of an Artificial Intelligence Management System

Risk management and compliance with ISO 42001 standards.

Protecting patient safety and sensitive data for all users

➜ Ensure GDPR compliance

• Preparation of the required documentation to guarantee data protection
• GDPR audit of your digital solutions.

➜ Cybersecurity training

Identification and management of potential vulnerabilities.

➜ Cybersecurity risk analysis

Awareness and best practices training for your teams.

Facilitate the deployment and integration of your
digital solutions into the healthcare ecosystem

➜ Interoperability strategy and framework

Implementation of connected solutions compliant with interoperability and security standards.

➜ State tele-services

Assessment of available solutions, resource identification, and support for integration.

➜ Compliance with the Interoperability and Security Framework

Validation by the French Digital Health Agency (Agence du Numérique en Santé).