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

Posted 01 April 2011 | By Lianne Coppinger 

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

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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