Why Should You Attend:
The responsibilities of proving liability on the part of the medical device expert witness are extremely challenging and require a knowledge of FDA regulatory protocols including premarket approvals and FDA design controls; good design practices for all types of medical design practices; an expertise in the research and development of medical devices; and the proper use of medical devices. The Expert Witness may be required to develop a written report which should be based on a rigorous engineering analysis of the device and experiences and knowledge of the proper functioning of the device which he/she has been requested to provide his/her opinions for the potential cause(s) of a device which has not provided the appropriate therapy as it had been designed for. This report needs to be well written and include a discussion of the adherence or lack of adherence to FDA device controls.
Experts should have a thorough background in FDA regulatory and EU control issue related to the specific device which there are providing their Expert Opinions on. More specifically The Expert should have the expertise in the following regulatory issues/protocols:
Areas Covered in the Webinar:
Who Will Benefit:
Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.
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. ComplianceOnline 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.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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