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  • AI in Compliance Work: ColabON's Vision

    The following Promt generated this image: is the image with the vision statement "From Regulation to Registration," using the Colabon color scheme. If you need any further modifications or adjustments, please let me know! It's beautiful, but maybe a bit overloaded.

  • AI+ Regulation

    Save the date! On June 26, 2024, an exciting event on the topic of AI + Regulation will take place at the Kaufmännisches Berufsbildungszentrum (KBZ) in Zug. In addition to academic representatives, Arlette Schilter, CEO of ColabON, will give a lecture on AI in Compliance Work. We would be delighted to welcome industry representatives to this event. Why should you participate? Learn about the latest developments in the field of AI and Regulation. Gain insights into the practical application of "AI in Compliance Work". Date: 26. Juni 2024 Time: 15:00 - 18:00 Uhr Anschließend Apéro Location: KBZ (Kaufmännisches Berufsbildungszentrum), Aabachstrasse 7 6301 Zug Further Informationen: Further details about the event will be provided shortly on the homepage von «Swiss Network for Digital Medical Regulation» (SNDMR). This event is organized in collaboration with the Business Development Division of the Canton of Zug. ColabON: ColabON: Your central hub for AI Regulation and harmonized AI standards With ColabON, you can access all relevant regulations, including those in the field of Artificial Intelligence (AI) – compactly and comprehensively prepared. Comprehensive Database: Our digital database includes all necessary regulations, including the planned harmonized norms for the Artificial Intelligence Act. Future-oriented: Furthermore, future harmonized norms and guidelines will be continuously integrated into our database. This ensures that you stay up-to-date with developments in AI regulation. #AIandRegulation

  • Current List of Harmonized Standards medical devices and IVDs

    Harmonized standard medical devices and IVDs Process standards Note: The harmonization of norms regarding the regulations MDR and IVDR is still ongoing. Therefore, this list is not exhaustive and may change over time. It is recommended to keep up-to-date with the official websites of relevant standardization bodies and notified bodies to obtain the most current information. Most of the european harmonized standards for medical devices are also mentioned by other international authorities. See here for information. Benefit of applying standards ColabON: Access to all data at clause level With ColabON, you gain access to all relevant norms and regulations for the medical device / in vitro diagnostic industry in a structured and easily understandable format. The data is provided at clause level, enabling you to conduct precise and detailed analysis. The Standard Harmonization Plans Mandate M/575 - C(2021)2406 : 2021-03-12 M/575 Amd 1 – C(2023)694 We have devoted significant effort to ensure the accuracy of this list, although its creation involves meticulous manual work. If you happen to spot any errors, we would greatly appreciate your feedback so that we can make the necessary corrections. We extend our gratitude to SWITEC and SNV for their invaluable expert contributions. Publications in the Official Journal Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council Amendment of 4 January 2022 to Implementing Decision (EU) 2021/1182 Amendment of 11 May 2022 to Implementing Decision (EU) 2021/1182 Amendment of 4 July 2023 to Implementing Decision (EU) 2021/1182 Amendment of 6 March 2024 to Implementing Decision (EU) 2021/1182 Get the current and planned harmonized standard list for medical devices and ivds #harmonisedstandardsmedicaldevices #harmonizedstandardsmedicaldevices #listofharmonizedstandardsmedicaldevices #harmonisedstandardsivds #harmonizedstandardsivds

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