Impact of Device Changes on Biocompatibility
Автор: Nelson Labs
Загружено: 2023-06-28
Просмотров: 846
Описание:
Change is the one constant in life and that is absolutely the current climate in the medical device industry. This post-COVID19 era is riddled with supply chain roadblocks that medical device companies are working through on a daily basis. The options are typically finding a new material, a new supplier, and sometimes, both. The question that remains at the end of a device change is regarding device biocompatibility. In this webinar, we will go through case studies using a risk based approach to determine the best data to gather to ensure that devices are still safe for the patient and remain compliant to the most recent ISO standards.
Highlights from the presentation will include:
• Case studies
• Application of ISO 10093-1
• What is useful supplier information
• Risk based approach to changes
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