Objectives for the Learner:
By the end of the presentation, learners should be able to:
- Understand FDA classifications and approval pathways for medical devices.
- Recognize the importance of HIPAA regulations in protecting patient data.
- Identify cybersecurity best practices for healthcare software and devices.
- Apply risk management principles to medical device development and regulatory processes.
- Navigate post-market surveillance requirements for continued device safety and effectiveness.
About the Speaker-
Iryna Sizikova is an experienced healthcare professional with 17 years in the industry. She works for a U.S.-based dental equipment and software manufacturer operating in over 120 countries. Holding PMP and PSPO II certifications, she is currently pursuing CBAP certification. As Chapter Lead of Business Analysis and Documentation, she develops strategies to streamline regulatory compliance and accelerate medical device market entry.
She actively contributes to the International Institute of Business Analysis (IIBA) as a speaker, author, and advocate, sharing expertise on medical software development, risk management, and regulatory compliance. Additionally, she supports workplace inclusivity initiatives for people with disabilities. Fluent in four languages, she has lived and worked across two continents and is currently training for her Private Pilot License.