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CRC Press International Medical Device Clinical Investigations - Practical Approach

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Description

This comprehensive guide addresses the growing demand for clinical evidence in medical device development across global regulatory environments. Written by thirteen industry experts, the book provides practical strategies for planning, preparing, implementing, and closing medical device clinical investigations regardless of trial location. The second edition draws on real-world experience to deliver actionable guidance aligned with the Medical Device Directive and contemporary regulatory frameworks. Essential reading for professionals navigating the complex landscape of clinical trials, regulatory compliance, and healthcare purchaser requirements in an era of worldwide healthcare reform.

Key Features

Authored by thirteen renowned experts with practical industry experience in medical device clinical investigations and regulatory affairs.

Covers the complete clinical investigation lifecycle from planning and preparation through implementation and closeout phases.

References the Medical Device Directive whilst emphasising principles applicable across different international regulatory environments.

Addresses the increasing emphasis on clinical evidence required by both regulatory bodies and healthcare purchasers globally.

Second edition reflects current best practices and updated approaches to conducting clinical trials across diverse geographical locations.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
30 April 1999
Listed Since
22 January 2007

Barcode

No barcode data available

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