Highlighting the main components of the act
How the AI Act complements or adds to MDR requirements
Balancing innovation with safety
Strategies to navigate the AI Act
Examine critical regulatory pathways, with strategic insights for achieving market clearance/approval in the US and EU
Present streamlined approaches for planning and designing effective clinical studies, highlighting the benefits of budgeting early
Discuss efficient processes for regulatory submissions and applications, from clinical study conduct to market clearance/approval
Analysis of current trends in investment within the medical device sector and exploring what factors contribute to the investment gap
Discussing financial, operational and regulatory challenges that startups and small to medium-sized companies face in the industry and how to overcome them
Identifying potential solutions for improving the investment landscape
The impact of AI and cyber threats on medical devices
The cyber challenges 2025 may bring
How regulators and tech companies are meeting the AI challenge
Challenges and opportunities from a technology, economic perspective
Geopolitical, legal and regulatory changes and their impact from an ecosystem perspective
Discussing challenges in communication, project management, and regulatory compliance
Role of CROs in fostering innovation in medical device development
Case studies highlighting successful collaborations and lessons learned
Emerging trends and technologies shaping future collaborations
Planning of a robust study design
Common hurdles during the start-up phase
Adhering to timelines for event reporting to regulatory authorities
Considering financial aspects during the course of a study
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