From parts shortages to parts with incorrect finishes, there are many lessons to be learned from other industries when responding to RoHS-type laws. The medical devices industry can use the "lessons learned" by other businesses to competently approach eco-compliance.

This paper outlines a strategy for a proactive approach to eco-compliance in the production of medical devices. Without focusing on specific environmental or RoHS-type legislation, it also presents a strategy for compliance information gathering, storage and organization.

Keywords: Medical devices, medical industry, ecocompliance, environmental requirements, environmental regulations, RoHS, due diligence documentation, environmental documentation, technical compliance file, WEEE.">

Medical Electronics Symposium Conference Proceedings


MEDICAL DEVICES AND ECO-COMPLIANCE: A PROACTIVE APPROACH

Author: Krista Botsford
Company: 5-Trees LLC
Date Published: 1/31/2008   Conference: Medical Electronics Symposium


Abstract: Though not currently in the scope of the European Union's Restriction on the use of certain Hazardous Substances directive (EU RoHS), medical devices are addressed by China’s Management Methods for Controlling Pollution Caused by Electronic Information Products Regulation (China RoHS). Medical device companies are now "playing catch-up" when it comes to preparing and showing compliance with RoHS-type legislation.

From parts shortages to parts with incorrect finishes, there are many lessons to be learned from other industries when responding to RoHS-type laws. The medical devices industry can use the "lessons learned" by other businesses to competently approach eco-compliance.

This paper outlines a strategy for a proactive approach to eco-compliance in the production of medical devices. Without focusing on specific environmental or RoHS-type legislation, it also presents a strategy for compliance information gathering, storage and organization.

Keywords: Medical devices, medical industry, ecocompliance, environmental requirements, environmental regulations, RoHS, due diligence documentation, environmental documentation, technical compliance file, WEEE.



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