Events

Product Related Cybersecurity: New EU and FDA Requirements

12.12.2025 – 12:00 AM to 12:45 AM | Online

As cybersecurity threats continue to evolve, both EU and US regulatory frameworks have made product-related security an important part of device design and the post-production phase. The MDR, MDCG 2019-16, and the IEC 81001-5-1 norm, paired with the FDA’s 2025 Guidance for Cybersecurity in Medical Devices require manufacturers to demonstrate a structured, end to end approach to cybersecurity, from requirements engineering, via risk management and secure development to post-market monitoring and incident response.

In this webinar, Dirk Müller, our Head of Cybersecurity Consulting Services, explains how to integrate cybersecurity into the quality management system and product development workflows so that security is treated as a core attribute of product quality, instead as an afterthought. Participants will gain insight into the latest compliance expectations and discover how a structured, security framework builds resilience, trust, and corporate value.

Do not miss this webinar if you hold any of the following positions in the MedTech industry:

• Quality Assurance
• Regulatory Affairs
• R&D
• PMS
• Cybersecurity Teams
• Any other role interested in increasing Cybersecurity within the organisation