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Assessing AI in Medical Devices and Applications

Minimize regulatory compliance issues during certification and surveillance audits, as well as technical documentation

Overview of Artificial Intelligence in Medical Devices

Artificial intelligence can be defined as “[a] machine’s ability to make decisions and perform tasks that simulate human intelligence and behavior.” The techniques to incorporate artificial intelligence methodologies in medical devices are based on the underlying algorithm. Today, there is a strong shift in the medical devices industry towards deep learning techniques using neural networks.

Neural networks refer to a set of algorithms that are modeled loosely after the human brain and designed to recognize patterns. When exposed to data through neural networks, the deep learning techniques of machines are able to mimic human learning patterns and change without being programmed.

Artificial intelligence in medical devices is employed to fulfill human capabilities in a variety of roles with deep learning techniques using neural networks, which include, but are not limited to:

  • Prediction and identification of diseases
  • Data classification and analysis for disease outbreak
  • Optimization of medical therapy
  • Diagnostic support application

Harness the Power of Artificial Intelligence in Medical Devices

Regarded as a transformative technology in the digital world, artificial intelligence or AI is bringing value to the field of medical devices today. As medical devices continue to incorporate artificial intelligence to perform or support medical applications, new regulations set forth by regulators, such as the Medical Device Regulation (MDR), In Vitro Medical Device Regulation (IVDR) and U.S. Food and Drug Administration (FDA), require AI-driven medical devices to comply with state-of-the-art requirements and provide objective evidence for repeatability and reliability.

While standards and guidelines are at an early stage of development to support these, manufacturers must evaluate the performativity of artificial intelligence techniques in their medical devices, pertaining to, but not limited to, areas in training and verification data, algorithm creation and risk management.

How We Can Help You

TÜV SÜD possesses leading competence in assessing AI in medical devices and applications. Our team of experts in medical devices and healthcare provide rich technical expertise to manufacturers who want to harness the capabilities of artificial intelligence in medical devices and improve the quality of global healthcare. With a sound understanding of the regulatory safety and performance standards, we assess if manufacturers meet the state of the art requirements of AI driven medical devices to minimize regulatory compliance issues during certification and surveillance audits, as well as technical documentation.

TÜV SÜD provides the following services to address the regulatory compliance of artificial intelligence in medical devices:

  • TÜV Mark: We provide the TÜV mark certificate to manufacturers who comply with state-of-the-art requirements on AI in medical devices upon an evaluation. This includes a yearly audit to assess manufacturer compliance with global regulatory standards.
  • Technical Documentation Review: We perform technical documentation review according to certification schemes prescribed by MDR and IVDR on the use of AI in medical devices.
  • Technical Meetings: We provide technical meetings to address the special aspects of AI in medical devices to comply with the General Safety and Performance Requirements and other regulations.
  • Trainings: We provide training on the current status of regulatory requirements and standards of AI in medical devices with reference to the requirements of medical AI.

Why Choose Us

As a trusted partner of choice for safety, security and sustainability solutions, TÜV SÜD adds value to society by assessing medical device manufacturers and build trust in new technologies and its competencies, such as those in software compliance and cybersecurity. Our comprehensive portfolio of testing, certification, auditing and advisory services are continuously updated to assess manufacturers to manage associated technology-related risks more effectively and successfully complete conformity assessments required for medical devices in EU and other international requirements for medical devices driven by new technologies.

Your Benefits at a glance

  • Recognized medical device expertise in new technologies - TÜV SÜD’s competencies in meeting the regulatory requirements of new technologies are supported by a team of digital medical and healthcare experts. We provide rich technical and regulatory expertise to medical device manufacturers leveraging new technologies and help them achieve global acceptance.
  • Outstanding track record in quality and safety - TÜV SÜD's software experts, AI experts and data-scientist evaluate medical devices that harness new technologies for safety through consistent regulatory reviews and assessments, so that the manufacturers fulfil their objectives and improve the overall quality of healthcare.
  • Active involvement in meeting global standards and implementation of new technologiesTÜV SÜD continuously anticipates technological developments in the medical device industry to help manufacturers meet new and changing regulatory requirements. This is underpinned by our leading competencies in assessing the regulatory compliance of artificial intelligence and other transformative methodologies in medical devices.

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AI in medical devices
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Artificial Intelligence in Medical Devices

Verifying and validating AI-based medical devices

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