Rina Wahlroos
Rina Wahlroos is VP, Quality, Regulatory Compliance and Customer Excellence at Aidian, bringing more than 20 years of experience in diagnostics and life sciences. She has held senior leadership roles at Thermo Fisher Scientific and PerkinElmer and has led major regulatory, quality and organisational transformations, including the implementation of the EU IVDR across a broad IVD portfolio.
Her leadership approach combines deep regulatory understanding with business perspective, customer focus and pragmatic, risk-based decision-making. Rina is passionate about creating clarity in complex environments, challenging established ways of working and building organisations that can move with confidence while maintaining trust and compliance.
Topics
How to Keep Your IVDR CE Certificate: Insights from Follow-Up Audits and Real-World Challenges
Obtaining an IVDR CE certificate is a major milestone, but it is only the beginning. As organisations move from initial certification into follow-up audits and technical documentation reviews, new challenges and questions inevitably emerge. This session will share perspectives and observations from operating under the IVDR after certification.
Rather than responding to every challenge by adding more processes, controls and documentation, the session will consider the role of risk-based thinking and informed decision-making. Ultimately, maintaining an IVDR CE certificate requires the ability to adapt, prioritise and make sound decisions in a complex regulatory environment.