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
Our consulting services are tailored to assist medical device manufacturers in navigating thee complex landscapes, ensuring compliance, and facilitating the succesful integration of AI/ML technologies into their products.
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.
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Navigating Regulatory Frameworks: FDA and EU Guidelines for AI/ML-Based Medical Devices
The FDA has established a comprehensive framework for the regulation of AI/ML-based medical devices, including:
- 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.
More details are on the FDA website.
The EU AI Act, adopted in May 2024, introduces a comprehensive regulatory framework for AI systems, with specific implications for medical devices:
- 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.
More details on MedTech Europe's perspective on the final AI Act and its impact on the medical technology industry. Are you up to the challenge?
The upcoming EU AI Act will have significant implications for medical devices incorporating artificial intelligence.
Watch the on-demand webinar to explore the key highlights of the new EU AI Act and its impact on the medical device and in vitro diagnostic (IVD) industry. This webinar delves into the regulatory changes and compliance requirements for manufacturers utilizing artificial intelligence in their products.
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Qserve's services to support AI medical devices
How can Qserve help
Our consulting services are tailored to assist medical device manufacturers in navigating these complex regulatory landscapes, ensuring compliance, and facilitating the successful integration of AI/ML technologies into their products.
Services we offer:
Training on the EU AI Act
Training on the EU AI Act and the impact on manufacturers intending to put AI medical devices on the European market.
This training includes an analysis of the EU AI Act and it’s consequences for manufacturers of AI medical devices who wish to put their AI medical devices on the European market. It will cover qualification and classification of AI medical devices, QMS implications, additional Technical file requirements, including Risk Management, Conformity Assessment and Post-Market Monitoring. Attendees of this training should be able to conduct a high-level impact assessment of the EU AI Act on their devices.
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Training / Workshop Regulatory Strategy for EU AI Act
In this training, a regulatory strategy for compliance with the EU AI Act will be discussed. This is especially relevant for AI medical device manufacturers with MDD/IVDD and/or MDR/IVDR certified devices on the market since the EU AI Act assumes a single Conformity Assessment, covering both MDR/IVDR and AI Act requirements. Alignment with the transitional timelines under the AI Act and compliance with forthcoming harmonized standards under the AI Act will be incorporated into the regulatory strategy, as well as alignment with already existing regulatory strategies for MDR/IVDR. Attendants should be able to develop a regulatory strategy for the EU AI Act and integrate it into the overall regulatory strategy for MDR/IVDR.
This training can also be offered as an in-house workshop, taking the existing company regulatory strategy as a starting point for integration of EU AI Act regulatory strategy requirements. The workshop's outcome should be a draft regulatory strategy to comply with the EU AI Act.
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Training EU AI Act impact on QMS processes
In order to support the EU AI Act requirements, specific processes will need to be established. This training will provide an overview of the QMS requirements from the EU AI Act, as well as an indication of how to integrate these requirements into an existing ISO 13485 Quality Management System. After the training, attendants should be able to perform a GAP assessment for the EU AI Act against an ISO 13485-compliant QMS. A GAP assessment template can be provided at an additional cost.
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Training clinical evaluation for AI devices, including EU MDR and EU AI Act requirements
A clinical evaluation for medical devices must be based on sufficient clinical data according to the EU MDR. For AI devices, sufficient clinical data covers in addition to the EU MDR requirements, three other sets of requirements:
- A properly justified training dataset, a validation dataset, and a test dataset per article 10 of the EU AI Act;
- Accuracy and robustness of the AI during the lifecycle according to article 15 of the EU AI Act;
- The requirements from MDCG 2020-1 Clinical evaluation for software: scientific validity, analytical performance (also called technical performance) and clinical performance.
This training will provide an overview of the abovementioned requirements, as well as how these requirements can be covered in a clinical evaluation. After the training, attendants should be able to explain the requirements for a clinical evaluation for AI medical devices and how those requirements can be integrated in a clinical evaluation.
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GAP assessment Good Machine Learning Practices and EU AI Act
For manufacturers already meeting the requirements of the Good Machine Learning Practices (GMLP) as implemented by the FDA, Health Canada, and the MHRA, Qserve provides a GAP assessment service against the EU AI Act. For this service, Qserve developed a template to indicate the GAPS and identify actions to be taken to come into compliance with the EU AI Act.
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AI medical device QMS implementation and support
Qserve can support the implementation of the EU AI Act process requirements into an existing compliant ISO 13485 QMS. This service will include templates for the additional processes on top of the ISO 13485 QMS processes and support to implement these processes in the manufacturer's (e)QMS.
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AI Technical Documentation support for GMLP and EU AI Act
Qserve can help set up technical documentation to support the EU AI Act requirements. The Technical File templates, including updated Risk Management templates, are included, as well as support for implementing these templates into the manufacturer's existing Technical File.
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Clinical evaluation support for GMLP and EU AI Act
Qserve can support the writing of the clinical evaluation for medical devices that need to comply with both the EU MDR/EU IVDR and the EU AI Act. The templates used to write the clinical evaluation and to document the literature search and appraisal are included in this service.
Qserve can also support manufacturers that have an EU MDR or EU IVDR compliant clinical evaluation, to cover the requirements from the EU AI Act.
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