Mastering Safety Risk Management for Medical and In Vitro Devices - Paperback
$100.80
Skip to product information
Mastering Safety Risk Management for Medical and In Vitro Devices - Paperback
$100.80
by Jayet Moon (Author), Arun Mathew (Author)
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
Number of Pages: 306
Dimensions: 0.64 x 9 x 6 IN
Publication Date: May 10, 2024
Details
This product is crafted with quality materials to ensure durability and performance. Designed with your convenience in mind, it seamlessly fits into your everyday life.
Shipping & Returns
We strive to process and ship all orders in a timely manner, working diligently to ensure that your items are on their way to you as soon as possible.
We are committed to ensuring a positive shopping experience for all our customers. If for any reason you wish to return an item, we invite you to reach out to our team for assistance, and we will evaluate every return request with care and consideration.
