Since the European Union Medical Devices Regulations 2017/745 (MDR) entered in force, medical device producers have been having busy times in adapting their processes and documentation in order to ensure compliance with the MDR requirements. The challenge of the MDR comes together with revisions of the clinical investigation ISO standard as well as notified bodies building additional clinical expertise and undergoing their designation under the MDR. In this challenging regulatory environment, the anticipation of changes and reorganisation of clinical evidence and clinical teams becomes crucial to maintain CE marking or acquire new registrations. The MedDev day is a medical device conference focusing on:
- The latest developments of the MDR implementation regulation and notified body designation process.
- Team structure and how to adapt to regulatory changes.
- Successful clinical evaluation plans and related clinical documents.
- Design and statistical considerations for successful clinical evaluations of medical devices.
- How to comply with post-market surveillance requirements.
- Medical devices regulatory documents and publications writing
MedDev Day is a medical device conference that gives insight into changes in the clinical and regulatory environment for the medical device industry for:
- Medical Device and Pharma industry, CROs, Regulatory Authorities and Academia experts on
- clinical trials
- data management
- medical writing
The MedDev Day is organised and managed by LS Academy according to the code of good conduct, to ensure the higher scientific quality of contents. All participants (attendees, speakers, moderators) are asked not to promote any product or service. Only sponsors can promote their commercial activities and products in one-to-one and/or at booth meetings.
Furthermore, at the end of MedDev Day, all participants are asked to provide their feedback through ad-hoc questionnaires. The answers are carefully revised and analysed by LS Academy together with speakers, moderators and sponsors to ensure the satisfaction of those that will attend future MedDev Days.
We look forward to meeting you at the MedDev Day on …. in …