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Regulatory Focus™ > News Articles > Quality & Compliance: OEM and CM: The Often Unexpected Division of Regulatory Responsibilities

Quality & Compliance: OEM and CM: The Often Unexpected Division of Regulatory Responsibilities

Posted 01 April 2011 | By Lianne Coppinger 

Medical device original equipment manufacturers (OEMs) preparing to commercialize innovative technologies sometimes mistakenly assume that outsourcing product manufacturing frees them from certain regulatory requirements. In reality, however, a contract manufacturer (CM) cannot offload these compulsory duties from the OEM.

 

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