Shaloo Sood
Team Leader - RDI Academy Straumann Group
Dr. Shaloo Sood is a senior medical device professional with extensive experience in product development, regulatory affairs, medical device software development, and global compliance strategies.
Shaloo Sood is Team Leader at the RDI Academy at Straumann, where she leads life cycle management, risk analysis, compliance assessment, and training. She brings deep expertise in risk management, verification and validation strategy, computer system validation, and V&V for mHealth and eHealth solutions, with strong knowledge of EU AI Act, MDR, IVDR, ISO 14971, IEC 62304, and 21 CFR 820.
A Ph.D. in Biotechnology and Experimental Medicine, she also has a strong academic foundation in research methodology, immunology, and medical instrumentation. She is a member of RAPS Swiss Chapter and is actively involved in teaching, mentoring, and knowledge-sharing across the regulatory, quality, and medical device community.
Seminars
- 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?
