Kristen Flaherty
Software QA Manager FIRE1
Kristen Flaherty is a design quality assurance and regulatory affairs professional with more than 12 years of experience driving process transformation across the medical device industry. She combines expertise in software engineering, risk and cybersecurity management, and global regulatory requirements to support the development of safe, effective, and compliant medical technologies. Kristen is known for implementing pragmatic, least-burdensome product development approaches that maximize quality, efficiency, and customer satisfaction. Passionate about education and mentorship, she excels at translating complex technical and regulatory concepts into clear, actionable guidance. Her work helps organizations accelerate innovation while maintaining the highest standards of safety, quality, and compliance.
Seminars
- 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
