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.
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:
Founder and President, Medical Device Safety Group Inc
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).
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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