ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
URS Provides Compliance Auditing and Risk Assessment Services against the requirement of ISO14971: 2007
URS offers various services worldwide and these services with accreditations where applicable, whilst following uniform management system, are operated by separate legal entities within the group. For status of individual scheme and accreditation, contact URS office or email at info@ursindia.com
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