Monday, February 19, 2024 | 11am EST | 8am PST | 5pm CET
Event Overview
Cytotoxicity is one of the most common assays performed as a part of medical device biocompatibility assessments. It is also very sensitive, and as a result many medical device companies find themselves having to handle positive cytotoxicity results with their products. These results need to be addressed, though they should be treated as a question that needs to be answered rather than a definitive flaw in the product. It may indeed be possible to demonstrate that the device in question is safe in its intended use despite the cytotoxicity results. Join us as we explore how to approach these cases and, when possible, make a safety case for a device despite positive cytotoxicity results.
Presenters:
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Geoffrey Moodie, Ph.D. Director, Biocompatibility Eurofins Medical Device Testing |
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As the Director of Biocompatibility at Eurofins Medical Device Testing, Dr. Moodie is responsible for conducting biological risk evaluations combining chemical, literature, and in vitro and in vivo test data. With over 20 years of experience with preclinical evaluation of a variety of implantable medical products, including combination products, his background includes leadership of biocompatibility evaluations at a leading medical device company covering an array of device types, from surface contact to fully implantable and limited to permanent duration, including those with bio erodible materials as well as biocompatibility evaluations of medical device packaging. Dr. Moodie holds a B.S. in Mechanical Engineering from the University of Massachusetts, Amherst and a Ph.D. in Medical Science from Brown University. Dr. Moodie also serves as a Board member and Vice President in charge of Programs at the Medical Development Group of Boston, a non-profit professional group dedicated to the education of medical technology professionals. |
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Paolo Pescio Technical Referent Eurofins Medical Device Testing |
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Paolo Pescio is a Technical Referent for Eurofins Medical Device Testing Milan. With more than 10 years of experience performing pre-clinical evaluation for medical devices, Mr. Pescio’s expertise lies in biological evaluation of medical devices, toxicological evaluation and risk assessment, Integrated Testing Strategies and E&L assessment. He is an active member of ISO TC194 and CEN TC206 groups for biological evaluation of medical devices and has chaired the Italian mirror committee for several years. Mr. Pescio earned a MSc in Biomedical Engineering from Polytechnic University of Milan (Italy) and a MSc in Applied Toxicology from University of Surrey (UK). |
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Event Overview
Cytotoxicity is one of the most common assays performed as a part of medical device biocompatibility assessments. It is also very sensitive, and as a result many medical device companies find themselves having to handle positive cytotoxicity results with their products. These results need to be addressed, though they should be treated as a question that needs to be answered rather than a definitive flaw in the product. It may indeed be possible to demonstrate that the device in question is safe in its intended use despite the cytotoxicity results. Join us as we explore how to approach these cases and, when possible, make a safety case for a device despite positive cytotoxicity results.
Presenters:
|
Geoffrey Moodie, Ph.D. Director, Biocompatibility Eurofins Medical Device Testing |
|
As the Director of Biocompatibility at Eurofins Medical Device Testing, Dr. Moodie is responsible for conducting biological risk evaluations combining chemical, literature, and in vitro and in vivo test data. With over 20 years of experience with preclinical evaluation of a variety of implantable medical products, including combination products, his background includes leadership of biocompatibility evaluations at a leading medical device company covering an array of device types, from surface contact to fully implantable and limited to permanent duration, including those with bio erodible materials as well as biocompatibility evaluations of medical device packaging. Dr. Moodie holds a B.S. in Mechanical Engineering from the University of Massachusetts, Amherst and a Ph.D. in Medical Science from Brown University. Dr. Moodie also serves as a Board member and Vice President in charge of Programs at the Medical Development Group of Boston, a non-profit professional group dedicated to the education of medical technology professionals. |
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Paolo Pescio Technical Referent Eurofins Medical Device Testing |
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Paolo Pescio is a Technical Referent for Eurofins Medical Device Testing Milan. With more than 10 years of experience performing pre-clinical evaluation for medical devices, Mr. Pescio’s expertise lies in biological evaluation of medical devices, toxicological evaluation and risk assessment, Integrated Testing Strategies and E&L assessment. He is an active member of ISO TC194 and CEN TC206 groups for biological evaluation of medical devices and has chaired the Italian mirror committee for several years. Mr. Pescio earned a MSc in Biomedical Engineering from Polytechnic University of Milan (Italy) and a MSc in Applied Toxicology from University of Surrey (UK). |
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