Technical Documentation Requirements for Device Approval in the EU

is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Tuesday, August 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.

The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.

This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.