Medical Device Laws & Regulations

On July 22, 2014, the Restriction of Hazardous Substances II legislative Directive becomes mandatory for medical devices and monitoring and control equipment placed on the market in the EU. Manufacturers, importers and distributors have specific obligations under this Directive.

This workshop, being held Nov. 19, 2013, at the AdvaMed Headquarters in Washington, D.C., will give attendees a firm understanding of current restricted substance regulations, as well as the process and documentation requirements of the expanded RoHS II legislation such as:

• The Process Requirements
• Determine information needed
• Collect and evaluate
• Periodic reassessment
• The Testing Requirements
• Homogeneous materials
• Historical perspective
• XRF screening
• Destructive analytical tests
• Current standards and evolution

Industry experts will discuss topics that will enable to you learn about key aspects of Restriction of Hazardous Substances, such as:

• Exemptions in the Directive
• Process requirements for compliance – non-destructive and destructive testing
• How to maintain and support ongoing compliance
• Resource needs to support these activities
• Procedures and paperwork needed for Declaration of Conformity.

Click here for more information.

Source: AdvaMed