IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next, using our CE Scoping checklist, we will walk through the essential IVDR documents. Additionally, we’ll discuss SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.

Goals for this webinar:

• Emphasize the importance of scoping
• Discuss how to develop a checklist
• Illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.

Click here to watch the recording of this webinar.

Leveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMCF Processes

Watch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR?

Key takeaways from the discussion include:

• Early implementation of structural process change across the organization can empower future success with IVDR submissions to the notified bodies
• What are the key documents and processes essential for successful alignment with IVDR regulations
• The importance of understanding the critical role of proactive and ongoing Systematic Literature Review search and screening activities
• Unexpected roadblocks