Mastering Safety Risk Management for Medical and In Vitro Devices (PDF)

Mastering Safety Risk Management for Medical and In Vitro Devices (PDF)

5 $

Format : Publisher PDF
File Size : 17.8 MB

Earn 5 points worth 5 $
Category:

By Jayet Moon, Arun Mathew 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).
Product Details

ASIN ‏ : ‎ B0D5FYMLL3
Publisher ‏ : ‎ ASQ Quality Press (10 May 2024)
Language ‏ : ‎ English

Reviews

There are no reviews yet.

Be the first to review “Mastering Safety Risk Management for Medical and In Vitro Devices (PDF)”

Related Products