Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs

The bar for clinical evidence for medical devices and IVDs to gain and maintain market access has never been greater. Regulators globally require a higher level of precision and granularity for clinical data to demonstrate safety and performance, in some cases even for well-established devices which have a long market history. Additionally, evolution in technology, drivers for demonstration of cost effectiveness of treatments, and increasing focus on ethical issues such as health equity pose challenges in terms of developing the right regulatory and clinical strategy.

This conference will examine the interplay between regulatory science, demonstration of device safety and performance, and development of an effective pre-and post- market clinical evidence strategy. It will also address critical operational issues including data management, statistics, cost effective study design, outsourcing, reimbursement planning and more.

The event is designed for regulatory and clinical leaders and decision makers in the medical device and IVD industry. Meet your colleagues and distinguished experts in clinical trials, reimbursement, regulations, and data management to share your thoughts, discuss hot topics and learn from each other.

We look forward to meeting you at The International Conference on Clinical Investigations, Regulation and Market Access for Medical Devices and IVDs (Horizon 2024)

Sincerely,