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January/February 2009

Editorial - Distinguishing Scandal from Management Problems

Environmental Legislation in the EU
Andrew Vaughan looks at requirements for medical device companies and discusses how they might change.

Change and the Regulatory Framework for Devices in the EU
Neena Brizmohun and Vibha Sharma report on the response to the European Commission's consultation on the proposed recast of the main medical device directives.

Ensuring a High Level of Business Conduct in the EU
Christopher Hodges discusses industry moves to ensure that companies adopt ethical business practices.

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Medical Device Approval in China and Hong Kong
Jack Wong describes the regulatory requirements for foreign manufacturers.

Professional Integrity Heads Regulatory News in 2008
Neena Brizmohun looks at regulatory developments that will shape the medical devices industry.

Plus:

Device-related Guidelines
International Standards
Meetings
Appointments
Directory of Services
Worldwide Update

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