In this webinar, Dr. Sarah Chavez discusses the Practical Strategies to Successfully Navigate Key IVDR Regulations Applicable to SaMD Devices. By the end of this webinar, you will gain a greater understanding of IVDR regulations' impact on SaMD products, enabling you to navigate the complexities of compliance and make informed decisions in your internal development processes.
Learning Objectives:
● Demystify IVDR Requirements for SaMD: Gain a clear understanding of the In Vitro Diagnostics Regulation (IVDR) and its specific implications for Software as a Medical Device (SaMD) in terms of classification, documentation, and conformity assessment.
● Interpret Rule 11: Dive deep into the nuances of Rule 11 under IVDR, focusing on how it classifies software with diagnostic or therapeutic purposes and the resulting impact on risk categorization (Class IIa, IIb, and III).
● Explore SaMD Categories: Navigate through the four SaMD categories based on their impact on patient or public health, unraveling the distinctions between software providing critical, serious, medium, or low-risk information.
● Harmonize with EU MDR 2017/745: Understand the interconnectedness of IVDR and the European Medical Device Regulation (EU MDR 2017/745), highlighting key changes in risk classification for SaMD and the implications for software developers.
● Craft a Compliance Strategy: Develop a strategic approach to ensure compliance with IVDR requirements for SaMD, covering essential aspects such as quality management, documentation, and early interactions with your notified body.
● Tackle Implementation Challenges: Address common challenges faced during the implementation of IVDR requirements for SaMD, exploring potential solutions and proactive measures to streamline the regulatory compliance process.
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