EU Batteries Regulation

Speaker Rossella Fontana

Date May 14th, 2025, Online

Duration 3 hours | 9:00 – 12:00 AM US Eastern Daylight Time, 3:00 – 6:00 PM Central Europe Summer Time

Virtual A recording will be available to registered participants, in case they are not able to attend all the live sessions.

For more information or questions, please contact: training@veranex.com

About the Speaker

Rossella is a PhD-level biomedical engineer with over 13 years of experience in the Medical Device Industry as R&D engineer, V&V system engineer, Project manager, and Q/RA manager. At Veranex, Rossella supports you during the design and development of active medical devices including active implantable medical devices, wearable devices and active hand-held instruments. She provides support with regulatory pathway assessment, EN ISO 13485 internal audit leading, electrical safety and risk management activities in accordance with IEC 60601 and ISO 14971, with verification and validation activities, and with the preparation of the technical documentation, according to the applicable regulatory requirements for submissions in the EU and in the US. 

TRAINING CONTENT  

• Introduction to EU 2023/1542 Batteries Regulation: Background, Scope and Applicability 
• Presentation of the main contents (Chapters and Annexes) and the new addressed topics 
• Diving into the Battery-related Requirements (e.g.: Articles 6, 7, 8...) 
• Focus on Medical Device Industry Compliance with EU 2023/1542: implications, deadlines and insights 
• Building and reviewing a concrete example of compliance for medical devices

TO WHOM IT IS ADDRESSED

The training is aimed at engineers, product managers, regulatory affairs specialists, or regulatory managers seeking to enhance their competence in this rapidly developing domain. 

PRICE  

EUR 350 including course material and certificate