Key Takeaways:
- The importance of planning and preparation before you even begin to actually write the SOA
- The complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)
- The potential impact your PER in case of incorrect/incomplete documents or processes
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
Criterion Edge provides free scoping of your PERs. Is it time to get them reviewed? Book your free consult.
