- TypeWebinar
- Location New York, United States
- Date 27-08-2021
Business Development
OTHERS
Live Webinar: State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs When: Friday August 27, 2021 - 01:00 PM Duration: 90 Minutes.
This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.
Why Should You Attend:
Both, the European MDR and MEDDEV 2.7.1 rev 4 requires that the risk/benefit analysis for any medical device be assessed considering the current state of the art and that the person performing the clinical evaluation of any clinical data be knowledgeable about the state of the art.
Areas Covered in the Webinar:
What is State of the Art (SOA)?
How does the SOA establish the context of the CER?
Recommended process and tools to write a thorough SOA
Where do we find the content to write an SOA?
How to write the different sub-Sections of an SOA
Recommended tools to summarize and present SOA clinical data
Recommended Literature search Strategy
What are the pitfalls of SOA writing?
How to build an SOA library for your products portfolio