Why Should You Attend: Understanding where to obtain the correct and current versions of international standards and guidance documents is crucial to properly designing, testing and obtaining approval for medical devices. There are numerous standards bodies and regulatory agencies throughout the world. A medical device manufacturer who wishes to market their device must know how to determine the applicable standards and insure that the current version is available. The same standards are available from multiple sources under different designations. Is an ISO standard the same as the EN ISO version and what about the BS EN ISO version? Are all of them needed? This seminar will help you understand the alphabet soup of standards.

Areas Covered in the Session:

• Sources of external standards / documents
  
• Standards Bodies – ISO, CEN, AAMI, etc
  
• Regulations – FDA, MDD, CMDR
  
• ISO, EN, BS EN, AAMI/ANSI – making sense of the standards alphabet soup
  
• Harmonized Standards – Source, meaning, updates
  
• Third Party sources of standards, ILI, BSI, etc.
  
• Keeping up to date
  
• Requirements, resources, transition periods
  
• Copyrights, filing, what standards do you need to have
  
• Discussion: Examples @ contractors, customers, etc

Who Will Benefit:

• QA Vice Presidents
  
• Directors and Managers
  
• Regulatory and Compliance Management
  
• Document Control Specialists Consultants
  
• Quality System Auditors