Burns & Associates, Inc.

Key Dates for Transition to the ISO 13485:2003 Standard:

European Union Transition Requirement:

• Quality systems subject to EU medical device directives must have registered to the new ISO 13485:2003 standard by July 2006.

Canadian Transition Requirements:

• All current ISO 13485 and ISO 13488 certificate holders must have completed transition to the new ISO 13485:2003 standard by March 14, 2006.

Maximizing the Value of Manufacturing & Service Organizations