We are very honored to be featured in the newsletter of the Swill network for digital medical regulation" written by Nicklaus Bühler.
Dr. Niklaus Bühler, Honorary Councilor ETH, Managing Director «Swiss Network for Digital Medical Regulation»
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A glimpse on the company ColabON AG:
The company ColabON AG is an AG with its registered office in Feldbrunnen-St. Niklaus, in the canton of Solothurn, which was founded in 2020. It is active in "programming activities".
Currently, the persons with decision-making power are Arlette Schilter (President) and Silvano Gauch (Member of the Board of Directors).
So many people in medical device organizations struggle to understand compliance.
ColabON masters the complexity of standards and regulations by: • Presenting the data in a unified format
Systematik interpretation features and queries
Change and update management
In order to make complexity manageable for all employees and for all manufactures, we need:
Efficient Processes for QMS •
Efficient Technical Documentation for international Registration •
Standard and Regulation Database
The database can be expanded to any laws, regulations and standards. Including the EU AI Act and their harmonized standards.
It is a general interest to support MedTech companies through strategic planning and early action to mitigate the impact of the EU-AI Act on medical devices. The goal is to help manufacturers ensure the regulatory compliance of their medical devices, as these can only be marketed in Switzerland and the EU under strict conditions.
Specific cases and the resulting regulatory requirements need to be identified and implemented. A legal assessment of the EU-AI Act is essential for medical device manufacturers who want to market their products in Switzerland or the EU.
To achieve this, specific use cases must be identified and the corresponding regulatory requirements under the AI Act must be implemented. A thorough legal assessment of the EU-AI Act is indispensable for medical device manufacturers looking to distribute their products in Switzerland or the EU.
With the publication of the EU-AI Act in June 2024 (Regulation (EU) 2024/1696), certain medical devices will automatically be classified as high-risk AI systems. For manufacturers of these products, it is crucial to understand and implement the new regulatory requirements. to medical devices, with only a few exceptions in the classification
As of June 13, 2024, Paragraph (179) of the EU-AI Act states the following regarding deadlines: This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated with the use of AI in certain ways, the prohibitions as well as the general provisions of this Regulation should already apply from 2 February 2025. While the full effect of those prohibitions follows with the establishment of the governance and enforcement of this Regulation, anticipating the application of the prohibitions is important to take account of unacceptable risks and to have an effect on other procedures, such as in civil law. Moreover, the infrastructure related to the governance and the conformity assessment system should be operational before 2 August 2026, therefore the provisions on notified bodies and governance structure should apply from 2 August 2025. Given the rapid pace of technological advancements and adoption of general-purpose AI models, obligations for providers of general-purpose AI models should apply from 2 August 2025.
ColabON is a Central Platform for Regulatory Requirements in AI Act and Medical Devices and Artificial Intelligence (AI)
ColabON offers a centralized regulatory database where regulations like the EU-AI Act can be interpreted and commented on. This platform is continuously updated in light of the new regulation, which is expected to also apply in Switzerland
ColabON is a service provider specializing in quality management and regulatory affairs for the MedTech industry. In addition to MDR (Medical Device Regulation), ColabON offers extensive support in applying the EU-AI Act.
With kind regards
Niklaus Bühler
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Thank you very Nicklaus.
SWISS NETWORK for DIGITAL MEDICAL REGULATION: https://swiss-digital-regulation.ch/
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