Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
In this webinar, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices,” defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data.
Additionally, we will touch on some examples of the types of clinical data that are appropriate to use for “legacy devices” for both MDR and IVDR requirements, and finally we will review the MDCG 2020-6 guidance on clinical data for “legacy devices.”
There will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. You can also submit your questions during the presentation.
Click here to watch the recording of this session.
Who should register for this webinar?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.
Post Market Surveillance: Systematic Literature Review and Case Study
Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.
- How leveraging published data can help meet regulatory expectations and inform internal decision-making
- Steps for conducting a methodologically-sound SLR
- How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies and support regulatory compliance.
Watch this free webinar here.