At ISS AG, we understand the challenges you face:
Regulatory Uncertainties
The ever-changing regulatory environment can pose challenges for companies looking to integrate AI into their products. Meeting regulatory requirements and engaging with regulatory authorities and notified bodies can be demanding.
Technical Documentation
Creating the necessary technical documentation for regulatory compliance can be time-consuming and complex. You may require assistance in compiling and preparing these documents.
We are here to help you at every step of the way
From strategic planning to ideation and use case development to achieving regulatory compliance, our experts will assist you in every step of your AI journey. We help identify compelling applications and guide you through the development process, ensuring that your solutions are clinically valuable and commercially viable.
Strategic Consultation
We assist you in strategic and ideation processes to integrate AI components into workflows and medical devices.
Data Assessment and Management
We support you in data-related questions, from acquisition to assessment, evaluation, and handling. We help you assess datasets' quality and identify biases to ensure that they meet the quality standards required for medical AI applications.
Training and Workshops
We offer training sessions and workshops to keep you updated on the latest advancements in AI in healthcare and equip you with the necessary skills.
Regulatory Support
Our experts guide you through the process of regulatory compliance to ensure that your AI tools adhere to applicable regulations and obtain necessary approvals. Additionally, we support you in creating the required technical documentation to meet regulatory standards.
Strategic Consulting
Every medical device begins with a precise definition of its intended purpose and scope. Especially in AI applications, a clear definition is important because small changes or adjustments can have significant impacts. We are here to assist you in crafting an optimal development strategy to enter the market successfully.
Regulatory Support
Consultation on existing regulations:
We advise you on the development of new AI products concerning the applicable regulatory requirements and guidelines that must be observed. Additionally, we will show you how to implement these requirements when developing your medical devices.
Interaction and negotiation with Authorities and Notified Bodies:
Our team of experts provides comprehensive support throughout your interaction with regulatory authorities and the approval or certification process for medical devices featuring AI components.
We advise you on the development of new AI products concerning the applicable regulatory requirements and guidelines that must be observed. Additionally, we will show you how to implement these requirements when developing your medical devices.
Interaction and negotiation with Authorities and Notified Bodies:
Our team of experts provides comprehensive support throughout your interaction with regulatory authorities and the approval or certification process for medical devices featuring AI components.
Data Assessment and Management
We support you in data-related questions, from acquisition to assessment, evaluation and handling. We help you to assess the quality of datasets and to identify biases to ensure that the datasets meet the quality standards required for medical AI applications.
Training and Workshops
Introduction to AI in a regulated environment:
This workshop not only provides an overview of the technology and specific challenges within the regulated environment for medical devices, but also equips you with the knowledge of regulations and requirements for AI tools, both in general and in the context of medical devices.
Prompt Engineering:
We offer training sessions on the effective use of AI tools in medical technology, including practical tips for enhancing performance and tailoring them to your specific needs.
This workshop not only provides an overview of the technology and specific challenges within the regulated environment for medical devices, but also equips you with the knowledge of regulations and requirements for AI tools, both in general and in the context of medical devices.
Prompt Engineering:
We offer training sessions on the effective use of AI tools in medical technology, including practical tips for enhancing performance and tailoring them to your specific needs.
Evaluation and Integration of AI Tools in the Development of Medical Devices
As the use of artificial intelligence (AI) in the development of medical devices continues to grow, the need for effective evaluation and integration of AI tools becomes increasingly urgent and significant. We understand the importance of this task and are here to guide you through it.
Evaluating new AI tools for specific tasks in the development of medical devices presents new challenges and uncertainties that require a thorough understanding of the technology. We provide support in the development of evaluation principles and the definition of criteria for the evaluation of new applications. Additionally, we support you in the deployment of widely used AI tools such as ChatGPT, Microsoft Co-Pilot, Google Gemini, etc., in the regulated environment of medical technology.
Integrating new AI tools into existing processes can be a complex task, but it's one we're well-equipped to handle. Our services include training employees in the use of AI tools and developing guidelines and standard operating procedures (SOPs) for their use in regulated environments. By partnering with us, you can ensure the safe and effective use of AI tools in your organization's existing processes.
How can we support you?
Contact us today to learn more about our services and how we can help you overcome your challenges in integrating AI into medical devices.
Samuel Kilchenmann, PhD
Senior Consultant Digital Health & AI
©
2025
ISS AG, Integrated Scientific Services