AI Act
Understanding compliance and navigating regulations for AI innovation
Support for AI Medical Devices to Meet GMLP and EU AI Act Compliance
Support for AI Medical Devices to Meet GMLP and EU AI Act Compliance
The European Union's Artificial Intelligence (AI) Act is a groundbreaking regulation designed to set the standard for AI governance worldwide. As AI technologies become increasingly integrated into various sectors, including healthcare, finance, and security, the need for clear and comprehensive regulations has never been more critical. The EU AI Act addresses this by categorizing AI systems based on their risk levels, from those that pose unacceptable dangers to those that require stricter oversight. This regulation is essential for businesses and innovators who must navigate these rules to ensure compliance, foster innovation, and maintain public trust in AI-driven solutions.
As artificial intelligence (AI) and machine learning (ML) technologies rapidly advance, their integration into medical devices presents both opportunities and challenges for manufacturers. Navigating the complex regulatory landscape is crucial to ensure compliance and successful product development. Our consulting services are designed to guide you through the intricate requirements set forth by the US Food and Drug Administration (FDA) and the recently published European Union's AI Act.
How Qserve can help
Training on the EU AI Act
Gain knowledge about the impact on manufacturers intending to put AI medical devices on the European market.
GAP assessment Good Machine Learning Practices and EU AI Act
We developed a template to indicate the GAPS and identify actions to be taken to come into compliance with the EU AI Act.
Clinical Evaluation support for GMLP and EU AI Act
We can support the writing of the clinical evaluaion for medical devices that need to comply with regulations.
AI Technical Documentation support for GMLP and EU AI Act
We can help set up technical documentation to support the requirements.
Workshop Regulatory Strategy for EU AI Act
Relevant for AI medical device manufacturers with MDD/IVDD and/or MDR/IVDR certified devices on the market.
Training EU AI Act impact on QMS processes
This training will provide an overview of the QMS requirements from the EU AI Act.
Navigating Regulatory Frameworks: FDA and EU Guidelines for AI/ML-Based Medical Devices
Navigating Regulatory Frameworks: FDA and EU Guidelines for AI/ML-Based Medical Devices
- Good Machine Learning Practices (GMLP) guidelines, emphasizing principles like data quality, model evaluation, and transparency.
- Design controls and risk management processes tailored for AI/ML systems, as outlined in 21 CFR Part 820.
- Specific guidance on software validation, off-the-shelf software (OTSS), and cybersecurity considerations. A proposed regulatory framework for modifications to AI/ML-based Software as a Medical Device (SaMD), addressing continuous learning systems and algorithm changes.
- Medical devices covered by the MDR or IVDR are classified as high-risk AI systems, subject to stringent requirements.
- Manufacturers must implement robust data governance and management practices for training, validation, and testing data sets. AI systems must be designed to enable effective human supervision and control during operation.
- Conformity assessments will be conducted in accordance with the MDR, IVDR, and the AI Act.
Stay Proactive with AI Compliance
Get in touch to hear more about our AI-related services for your medical device
Stay Proactive with AI Compliance
Get in touch to hear more about our AI-related services for your medical device