CHAPTER LEAD – SYSTEM ANALYSIS & DOCUMENTATION | DENTSPLY SIRONA
Iryna Sizikova
My name is Iryna Sizikova. I am IIBA member based in the US. For the past 17 years I have been working in the healthcare industry, at Dentsply Sirona, US dental equipment and software product manufacturer that markets its products in over 120 countries.
My current role is the Chapter Lead of the System Analysis and Documentation team.
Also, I am passionate to share my knowledge to other BAs.
Presentation: A matter of life and death – when your requirements traceability has to be right; the work of a BA in the health care industry.
From initial concept to regulatory submission, Business Analysts play an essential role in ensuring medical devices are developed with regulatory compliance and patient safety in mind. By driving clarity in requirements, supporting risk identification, and ensuring traceability between hazards, mitigations, and testing, a Business Analyst helps translate regulatory expectations into actionable and traceable requirements and designs. Their involvement in risk and cybersecurity management activities, design documentation control, and stakeholder alignment supports the creation of submission-ready artifacts that meet regulatory standards.
This session is designed for professionals supporting initiatives in both regulated and non-regulated industries who want to understand the regulatory approval process and grasp the important role Business Analysts play in it.