Clinical Evaluation Requirements in light of the MDR

Description
Regulatory

This recorded session provides an essential overview of the requirements of clinical evaluation as mandated by the MDR.  The trainer provides practical examples for different types of devices (e.g. implants, software) and covers determination of sufficient level of clinical evidence, literature screening and a clinical evaluation report (CER) writing.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • To evaluate the potential gaps in your organization related to clinical evaluation and CER development or required updates to comply with the new MDR requirements
  • To determine an action plan based on relevant requirements and processes to conduct clinical evaluation and produce a CER
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Zuzanna Kwade
Zuzanna Kwade is clinical post-market surveillance team lead at Agfa Healthcare. She is an active member of COCIR, the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries and represents COCIR in clinical evaluation of software task force at European level. Zuzanna has over 10 years of hands-on experience in clinical safety management in pharma and medical device studies. She holds a PhD in molecular biology.