Join Wen Schroeder February 26 -29 in our Live Streamed Classroom - Register Now!
All training until further notice will be offered by via live stream only. You will receive further information and instructions once you have registered. The Online Training will be delivered by way of Live interactive seminars. |
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| Next Course Date
February 26 - February 29, 2024 Live Streamed Classroom |
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| Wen Schroeder is the founder and president of SEKI Cosmeticals. With 20+ years of industrial experience, 30 US patents and author of numerous publications, Ms. Schroeder is an internationally recognized lecturer in medical device regulations & regulatory affairs covering a wide range of subject areas, including design product performance & safety testing programs for pharmaceutical, medical devices, and food products. |
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Course runs 12:00 - 5:00 ET / 9:00 - 2:00 PT The EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) came into force in 2017 to replace existing medical device directives. The main objective of these new regulations aims at improving/increasing patient safety, in particular, in areas such as clinical testing requirements, clinical efficacy, product registration, centralized product database, traceability, labeling, and post market surveillance, etc. A grace period was planned for each of these regulations to help the industry transition into full compliance. |
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By the end of this course, participants will: | |
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