The WMDS 2022 and WMDS 2023 identified the shortcomings of regulatory systems and defined the priorities of projects to address these issues.
Projects with the highest priority have been initiated and first results will be available. Among those are “regulatory intelligence”, “regulation as code” and “real-time validation of conformity”.
The goals of WMDS 2024 are to
network all actors in the medical device ecosystem to gain a common understanding and to remove the frictions in the current regulatory system.
finetune and update the picture of a perfect (global) regulatory system.
assess the project results and provide guidance and support for these projects.
learn from other industries how to improve the regulatory systems.
identify common and overlapping projects and areas of cooperation between regulatory bodies and other stakeholders.
identify the requirements, prerequisites, and general conditions of regulatory bodies (policy makers, authorities, notified bodies) to achieve real-time compliance and enforcement
The World Medical Device Summit
About the platform, goals, participants, retrospective, and status quo
The regulatory system(s) of the future
Alignment of goals and visions
Projects and initiatives worldwide
Current efforts and learnings, streamlining and harmonization of approaches
Regulation as Code
The core principles, the impact on regulatory systems, first results, and requirements for the regulator of the future
The core principles, changes for regulators and manufacturers, first results
Harmonization of regulatory systems
Updates by regulatory bodies, commonalities and differences, impact on process automation
Governments, policy makers, authorities
Manufacturers and manufacturer associations
Academia / Science
* Participant of previous summits
As in previous years the WMDS participants will meet in Konstanz, Germany for two days: May 15th – May 16th.