Part I: Friday 28 May 2021 09-12h
Part II: Friday 04 June 2021 09-12h
This online seminar consists of two parts spread over two days. It is not possible to register for a separate part. After the first part, intermediate insights and action points are being shared which you may use for preperation untill the next session. Presentation and documentation will be in English.
Medical device manufacturers
Clinical and regulatory professionals
A certificate of attendance will be delivered to each participant.
ARE YOU PREPARED FOR THE EU MEDICAL DEVICE REGULATION?
If you are a clinical and/or regulatory professional, you are well aware that the new MDR (MDR - 2017/745) enters into force as of 26 May 2021.
In this new regulation pro-active post-market surveillance (PMS) plays an essential role and is required for maintaining device certification and recertification.
But how will you plan and implement your post-market surveillance system in compliance with the new requirements?
WHAT CAN YOU EXPECT?
During this online seminar, part I on 28th of May and part II on the 4th of June, Archer Research was invited as a guest speaker to guide you in a stepwise manner through the extensive requirements, from pre-market towards a more post-market focus, which will enable you to continuously manage and improve your PMS.
Clinical Research Professionals, Mieke Tempels and Karen Gabriels will provide you with an in-depth outline of the post-market clinical follow-up (PMCF) as an integral part of your PMS. In your PMCF plan you should specify data sources and analytic methods in order to pro-actively show continued conformity with the requirements for device safety and performance.
But which sources of clinical evidence can be used and which are sufficient to show scientific validity for your medical device? We will tackle these questions with case studies and examples. This online event will be interactive, questions will be answered and most importantly, we are here to support you further along the way.
WHAT WILL YOU HAVE LEARNED?
You will learn the essentials on post-market surveillance under the MDR, and the key changes and impact on clinical trial needs and design. You will understand the steps to take for your company’s compliance to the MDR.
WHAT CAN YOU EXPECT FROM US AFTER THE EVENTS?
Archer Research provides in-company follow-up to establish a PMS and PMCF plan and to close your potential gap in clinical evidence. Subsequently our experts can assist with the reporting requirements and clinical evaluation updates.
This unique program allows you to learn the steps to take and receive company-specific support to guarantee a qualitative and efficient transition to the MDR.