Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation - Image 1

Price loading...

Books on Demand Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

Name: Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
Brand: Books on Demand

Law

Price History & Forecast

No Price Data Available

Price history will appear here once data is collected from Amazon.

Price Distribution

No price data available for histogram

Description

"The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups, spin-offs or other development projects or in counselling services." Dr. Tom Melvin, Co-Chair, Clinical Investigation and Evaluation Working Group

Product Specifications

Brand: Books on Demand
Format: paperback
ASIN: 3751937668
Category: Books > Subjects > Business, Finance & Law > Law
Domain: Amazon UK
Release Date: 04 June 2020
Listed Since: 05 June 2020

Barcode

No barcode data available

Books on Demand Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

CE-Marking

Medical Devices: European Union Policymaking and the Implementation of Health and Patient Safety in France

The Future of Medical Device Regulation: Innovation and Protection

Managing Medical Devices within a Regulatory Framework

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

CRC Press International Medical Device Clinical Investigations

Clinical Evaluation of Medical Devices: Principles and Case Studies

Clinical Evaluation of Medical Devices: Principles and Case Studies

Medical Device Design: Innovation from Concept to Market

Medical Devices: Regulations, Standards and Practices (Woodhead Publishing Series in Biomaterials)

Inspection of Medical Devices: For Regulatory Purposes (Series in Biomedical Engineering)

Malpractice and Medical Liability: European State of the Art and Guidelines

European Union Health Law

Medical Devices in Modern Healthcare: Current Research on New Materials and Engineering, Device Evaluation and Regulatory Implications

Medical Device Guidelines and Regulations Handbook

Medicines, Medical Devices and the Law

Clinical Engineering: A Handbook for Clinical and Biomedical Engineers

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

A Beginners Road Map to the Medical Device Industry

Guide to EU Pharmaceutical Regulatory Law

Medicines, Medical Devices and the Law

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

The Design and Management of Medical Device Clinical Trials: Strategies and Challenges

European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty