Shaloo Sood

• Aligning MDR, AI Act and cybersecurity requirements into a single compliance framework to reduce duplicated effort, improve traceability and streamline software development and documentation activities
• Identifying what requirements genuinely apply to products and use cases to avoid over-compliance, focus resources on high-risk areas and reduce unnecessary regulatory burden
• Preparing products for evolving regulatory expectations across global markets by developing scalable compliance strategies that support market readiness, accelerate submissions and improve interactions with auditors and regulators`

As AI capabilities rapidly transform software development, MedTech organisations face a critical question: should they accelerate adoption to capture productivity and innovation benefits, or wait for clearer regulatory expectations and governance frameworks to emerge? Join this interactive debate as industry leaders discuss whether moving fast creates a competitive advantage or introduces unacceptable quality, compliance and cybersecurity risks. Drawing on real-world experiences from software, regulatory, quality and cybersecurity teams, this session will explore how organisations can balance innovation with control in an increasingly AI-driven landscape.

Discussion points include:

• Should MedTech companies embrace AI today, or wait for greater regulatory clarity?
• Is moving too slowly on AI creating a bigger business risk than moving too quickly?
• How much validation and governance should be required before AI is deployed?
• Are human-in-the-loop requirements enabling trust or limiting innovation?