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For enhanced readability and navigability, we have overhauled the official version of the European AI regulation proposal and added a comprehensive table of contents as well as clickable cross-references.
consolidated version for enhanced readability
A summary on the CHI's whitepaper "Machine Learning and Medical Devices Connecting practice to policy (and back again)".
The regulatory requirements for pre-trained deep neural networks.
Founder
"I'm thrilled about the potential of AI and machine learning and eager to help to use it safely."
We are a small but mighty, owner-run business with profound hands-on expertise in the areas of machine learning, software validation, and AI regulation. Our passion is to help make the latest machine learning technology comply with conformity requirements in any safety-critical application domain.
The primary interest and focus of our customers – ranging from cutting-edge tech start-ups to leading technology providers and global pharmaceutical companies – is to develop innovative products with state-of-the-art technology. Our contribution is to help bring these products into the market fast, safely, and smoothly.
We know that relying on someone’s support in a such critical area requires trust, and that trust must grow over time. The best way to get to know us, our mode of operation, and the value we can bring to the table, is to get in touch with us. Together, we will figure out if our machine learning validation solutions are a good fit for your business needs. We will be happy to get back to you if you drop us a short note via our contact form.
We help you set up or adapt your AI and machine learning development process to comply with regulatory requirements such as the MDR and EU AI Regulation.
If you develop machine learning applications, you most likely use a library such as TensorFlow or Pytorch. Our generic library validation solution complies with regulatory requirements for their use.
We review your SOPs, work instructions, technical documentation, and risk-management file for regulatory conformity and audit safety.
We support your data science team in technical matters such as data quality assessment, model evaluation, bias prevention, and explainable AI.
Our in-house seminars covering AI and machine learning as well as regulatory aspects bring your teams up to speed and help document their acquired competencies.
Can't find the service you're looking for? We'll be happy to set you in contact with one of our partners.
We work very hard to make our customers happy - read what they have to say below.
"I took part in the one-day workshop Developing AI applications in compliance with the regulatory requirements and was delighted. Despite the online format, it was a very lively event with a dynamic discussion and active involvement of the participants. Prof. Haase understood how to present even very abstract contexts in a comprehensible way and how to break them down to regulatory tasks. It was noticeable that he was really interested in answering our questions and pointing out solutions to problems."
Quality Manager, Aignostics GmbH
"A very nice team, which flexibly adapts to customer requirements and has convinced with high expertise and practical experience. Through their expert support we are ideally prepared for the audit regarding the validation of Machine Learning."
Regulatory Affairs, FotoFinder Systems GmbH
