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A full day conference and a pre-conference workshop on "How to write a Clinical Evaluation Report from MDR Perspective"
Since the European Union Medical Devices Regulations 2017/745 (MDR) entered in force, economic operators have been having busy times in adapting their processes and documentation in order to ensure compliance to the MDR requirements by its date of application (DOA) in May 2020. For the economic operators 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, anticipation of changes and reorganisation of clinical evidence and clinical teams plays a pivotal role to maintain CE marking or acquire new registrations.
The first MedDev Day gives insight into changes in the clinical regulatory environment for medical device industry with a focus on:
- Latest developments of the MDR implementation regulation and notified body designation process.
- Insights on clinical team structure and how to adapt to regulatory changes.
- Successful clinical evaluation plans and related clinical documents such as post market clinical follow up (PMCF) plans and reports, post market surveillance (PMS) documentation, periodic safety update reports (PSURS) and summary of safety and performance characteristics (SSCP).
- Design and statistical considerations for successful clinical evaluations in the medical devices world.
- How to comply with post market surveillance (PMS) requirements from a clinical perspective.
MedDev Day combines a pre-conference workshop on clinical writing with a comprehensive overview on changes affecting the device industry all together with exchange of expertise and workshops.
It brings together quality, regulatory, clinical experts from Medical Devices and Pharma industry, CROs, Regulatory Authorities and Academia to share winning strategies, best practices and examples.
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA
Laura Michellini - Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Anna Bottura - Business Development Manager at Arithmos
Who should attend?
The event is addressed to professionals dealing with Medical Devices, belonging to department such as:
• Regulatory Affairs
• Device vigilance
• Medical Affairs
• Clinical Operations
from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.