About this event
MDR Software Classification & AI Act – Key Regulatory Considerations
Are you ready to understand the implications of the AI Act?
Medical Device Software (MDSW) remains a key focus under Regulation (EU) 2017/745 (MDR). With the entry into force of Regulation (EU) 2024/1689 (AI Act), manufacturers of AI-enabled medical devices must now navigate additional regulatory requirements, including risk classification and conformity assessment considerations.
In this DEKRA webinar, our regulatory experts will explain how these frameworks interact and provide a clear overview of:
- Determining and documenting MDSW classification under MDR
- Understanding AI system risk classification and its regulatory impact
- Where MDR and AI Act requirements intersect and diverge
- Preparing technical documentation and quality systems in line with regulatory expectations
Whether you are developing standalone software, integrating AI into existing devices, or reviewing your regulatory compliance, this session provides an informative overview of key regulatory considerations.
Hosted by
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External speaker
Sharon Kanety Deresh Project Manager, Lead Auditor, and Technical File Reviewer @ DEKRA Certification B.V.E
Sharon Kanety Deresh is a Project Manager, Lead Auditor, and Technical File Reviewer at DEKRA Certification B.V., where she has been active since 2021. She holds a B.Sc. in Mechanical Engineering with a specialization in Medical Engineering and Biomechanics. Sharon brings more than 20 years of experience in the medical device industry, covering active and non-active devices, including implants, as well as experience in the pharmaceutical sector.
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External speaker
Sharon Konforty Wissmark Project Manager, Lead Auditor, and Technical File Reviewer @ DEKRA Certification B.V.E
Sharon Konforty Wissmark is a Project Manager, Lead Auditor, and Technical File Reviewer at DEKRA Certification B.V. With over 20 years of experience in the medical device industry, she has extensive expertise in both active and non-active devices and supports manufacturers in regulatory compliance and technical documentation assessments. Sharon holds an M.Sc. in Industrial Engineering.
DEKRA
DEKRA is a global expert organization dedicated to safety, with over 48,000 employees in around 60 countries. They provide a wide range of independent expert services for safety in transportation, workplaces, and homes, including vehicle inspections, c...
