- Medical device clinical trials in Europe: an overview of the landscape
- Innovation and technology: what’s new, and what’s upcoming?
- Changes in technology, strategy and regulatory affairs for the European medical device industry
- Understanding the concept of PMCF studies mandated by EU MDR
- Working closely with notified bodies to comply with guidelines and regulations
- Use cases and best practice for medical device and drug-device combination products
- Outlining the specific digital transformation goals and requirements for medical device companies
- Overcoming operational challenges associated with medium-sized medical device companies
- Detailing a roadmap for successful clinical digitalization
- An overview of MDR Article 61.4, with a focus on performance and safety requirements for a clinical investigation of implantable and class III devices
- The impact on claiming equivalence, and the challenges med device sponsors are facing
- Key considerations for operationalizing medical device clinical investigations to achieve performance and safety data
- Understanding the reimbursement structure and its importance in clinical trials
- Variances in reimbursement across sites and countries, case studies highlighting the differences in reimbursement models
- Streamlining contract negotiations, mitigating delays and potential roadblocks
- Identifying common challenges faced during the negotiation phase
- Exploring potential developments and innovations in reimbursement strategies
- Understanding the need for AI and software incorporation to handle paperwork efficiently
- Exploring the potential for AI to make processes more efficient and improve patient outcomes
- Exploring the use of AI in accelerating data analysis during clinical trials
- Discussing how AI-powered data analysis can speed up clinical trial timelines
- Identifying opportunities for optimising trial efficiency through AI
- Discussing the benefits of AI in streamlining regulatory compliance
