Software, AI, and Regulatory Affairs with Metecon: Everything from a single source
Medical devices with software components are subject to complex regulatory requirements. At Metecon, we guide you through this complexity – from the software development lifecycle to CE marking, from EN 62304 and EN IEC 81001-5-1 to the AI Act.
At the Swiss Medtech Expo, we’ll show you:
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how to efficiently integrate regulatory requirements from MDR/IVDR, NIS2, GDPR, and the AI Act,
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how to future-proof your management system – including software, cybersecurity, and AI-related risks, and
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how to successfully align digitalization and compliance.
Visit our Metecon team at the Swiss Medtech joint booth and discover how we support you with strategic expertise, concrete solutions, and efficient clarity – so you can bring your software products to market safely and in compliance.
Would you like to get in touch before the event or discuss a specific challenge? Use our contact form or book a non-binding meeting with Peter Hartung, Senior Expert Active Medical Devices & Software:
👉 Schedule a meeting – non-binding & results-focused
We look forward to connecting with you – in person, with expertise, and a solution-oriented mindset.
