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.
Notified bodies are issuing formal citations for non-conformities in clinical evaluation reports of medical devices, specifically pertaining to the state-of-the-art analysis.
SOAs, if not written with their main intent in mind, often fail to provide context for whether the subject device in the CER addresses a significant gap in managing the medical condition. The SOAs also fail to demonstrate whether the subject device has an improved or at least equivalent benefit/risk profile compared to existing devices or therapies.
This webinar will help you prevent these failures, teach you how to efficiently prepare before writing an SOA and show you how to best write and present your clinical data in each section of the SOA. Additionally, recommendations will be provided to build your own SOA Library to meet CER update timelines for your products portfolio.
Areas Covered in the Webinar:
Who Will Benefit:
Maria Sanchez is the founder and President of Medical Device Safety Group, Inc., a consulting company providing quality services for medical device manufacturers.
Ms. Sanchez has more than 10 years’ experience in complaint handling processes, post-market safety surveillance, risk management, and Clinical Evaluation Reports in medical device companies.
Ms. Sanchez holds a Master in Business Administration (MBA) and a Bachelor’s in Science of Nursing (BSN). Additionally, she is a Certified Quality Auditor (CQA) and Manager of Quality/Organizational Excellence from the American Society for Quality (ASQ).
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