£118.88

Beuth Verlag - Risikomanagement Medizinprodukte ISO 14971

Name: Beuth Verlag - Risikomanagement Medizinprodukte ISO 14971
Brand: Beuth Verlag
Price: 118.88 GBP
Availability: InStock

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Description

Navigate the mandatory requirements of the EU Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR) with this professional guide. As transition periods have ended, compliance with these regulations is essential for all manufacturers. This book provides a practical approach to implementing risk management processes based on the latest DIN EN ISO 14971 (2022 edition). It offers direct reference to current standards to help users manage risk management processes effectively in a professional setting. The guide also includes relevant information regarding guidance documents such as ISO/TR 24971 and ISO/TR to ensure comprehensive coverage of the regulatory landscape for medical devices and in-vitro diagnostics.

Key Features

This guide provides practical implementation steps for the DIN EN ISO 14971 standard specifically updated to the 2022 edition.

The content addresses the mandatory application of the EU Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR).

Users receive direct and current standard references for managing risk management processes within the medical device industry.

The book covers essential guidance documents including ISO/TR 24971 and ISO/TR to support professional risk management.

Published by Beuth Verlag, this resource serves as a specialized manual for compliance with current EU medical regulations.

Product Specifications

Brand: Beuth Verlag
Format: paperback
ASIN: 3410315276
Category: Books > Subjects > Business, Finance & Law > Management
Domain: Amazon UK
Release Date: 12 May 2023
Listed Since: 28 December 2022

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Beuth Verlag - Risikomanagement Medizinprodukte ISO 14971

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