Services

Services

Our interdisciplinary network of academics, legal experts, data scientists, computer scientists and AI experts deliver comprehensive legal, ethical and practical guidance for the development and adoption of advanced technologies in private and public organisations, such as AI, robotics, IoT systems, quantum computing, cloud, medical devices.
SmartLex ensures seamless compliance with relevant EU and national legislation in the following domains:

  • Artificial Intelligence, providing advisory services for the implementation of the risk management system, Fundamental Rights Impact Assessment, and AI literacy requirements;
  • Cybersecurity, enhancing organisations’ cybersecurity capabilities and ensuring legal compliance (e.g. NIS2) with the national cybersecurity policies on chain security, vulnerability management, and awareness;
  • Data protection, ensuring compliance for personal data processing (e.g. GDPR), as well as secondary use of data (e.g. DGA, EHDS), also through automated tools and services;
  • Medical Devices, IoT, and Robotics, enabling legal and ethical by default procedures along the entire product lifecycle (e.g. MDR, GPSR)

SmartLex assists in legal compliance by design for AI development and for Cybersecurity governance, also by offering audit activities for ISO/IEC 27001:2022 and ISO/IEC 42001:2023

ARTIFICIAL INTELLIGENCE

  • AI Act compliance for AI development and use
  • AI risk management frameworks (ISO/IEC 42001:2023)
  • Fundamental rights impact assessments
  • ISO/IEC 42001:2023 audit and certification support

CYBERSECURITY

  • Security policy design, deployment and audit (ISO/IEC 27001:2022)
  • NIS 2 compliance, audit and certification support
  • Risk analysis and ICT procurement management
  • Supply chain security positioning, accountability and liability

DATA PROTECTION

  • GDPR compliance
  • Data sharing and cross-border data transfer
  • Data protection impact assessment
  • Secondary use of data (DGA/EHDS implementation)

DIGITAL GOVERNANCE

  • Cloud migration and acquisition compliance (CAN certification)
  • Digital services legal requirements
  • ICT procurement management
  • Post-quantum capacity transition governance

IOT AND MEDICAL DEVICE

  • Medical devices regulation
  • CE marketing requirements
  • IoT and robotics safety standards
  • Product liability risk mitigation

Compliance automation tools, tailored for PPAA SMEs and enterprises.

1
COMPREHENSIVE SERVICE MODEL

We transform regulatory constraints into business opportunities through our unique combination of legal, ethical, and technical expertise.

2
STRATEGIC ROADMAP DEVELOPMENT

We create customized, realistic, and timely compliance plans that integrate all relevant regulatory requirements for your organization.

3
CAPACITY BUILDING & TRAINING

We make your organization more competitive through specialized training programs that raise expertise and awareness at all levels.

4
CONTINUOUS IMPROVEMENT

We keep you consistently compliant through constant monitoring of regulations, periodic assessments, and process optimization.

Coesione Italia
Image