Software and Artificial Intelligence.
Regulatory strategy and compliance for SaMD, embedded software, and AI-based systems
Compliance is not only about classification under MDR/IVDR, but involves theentire software lifecycle: architecture, risk management, clinical validation, cybersecurity, updates, and post-market monitoring. In the case of systems with AI or machine learning, there are additional requirements related to transparency, data governance, change control, and interaction with the future European regulatory framework (AI Act).
Software as a Medical Device (SaMD)
Comprehensive regulatory support for software qualified as medical devices under the MDR, including digital health solutions.
We support the manufacturer in:
- qualification and classification
- Definition of ISO 62304-compliant architecture
- risk management
- clinical validation and integration into the ERC
- preparation of technical documentation
Artificial Intelligence.
Regulatory support for medical devices and IVDs that integrate artificial intelligence-based systems.
We support the manufacturer in:
- ISO 42001 compliance and Regulation 2024/1689
- definition of MDR + AI Act regulatory strategy
- data management and data governance
- validation and verification of algorithms
- change control and versioning
- bias management and model robustness
- integration of AI component into technical documentation
FAQ - SaMD (Software as a Medical Device).
The most frequently asked questions we receive from Manufacturers, startups and developers of digital health solutions.
Are you looking for an experienced and reliable CRO for medical device consulting?
We design and manage all phases of the clinical investigation through our team of highly qualified professionals.