Kristen Flaherty
Software QA Manager FIRE1
Seminars
Thursday 10th December 2026
Leveraging Cross-Functional Collaboration Between Software, Quality & Regulatory Teams to Scale Digital Health Solutions, Navigate Regulatory Complexity & Accelerate Market Expansion
3:45 pm
- Aligning software, quality, clinical and regulatory stakeholders around common objectives to support the development, validation and commercialisation of connected digital health solutions while maintaining focus on patient outcomes and safety
- Managing risk, cybersecurity and regulatory expectations throughout the product lifecycle by strengthening risk assessment processes, adopting new validation approaches and navigating increasingly complex FDA-led submission requirements
- Scaling people, processes and operational capabilities to support global growth by balancing outsourced development models, complaint management, customer support functions and future expansion across the US, Europe and additional international markets
