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What Is The Purpose Of Medical Design

Decent Essays
1) The Regulatory affairs specialist make sure the final product (medical equipment) seeking the regulatory approval meet all the demands of the Medical Devices Quality System Regulations and other standards proposed by the Regulatory body of a particular region or jurisdiction . The RA Specialists are responsible for the timely completion of Regulatory documents and its associated processes. This need to be done after conducting the review, verification and analysis of the Technical documentation, Safety and Operational Performance of the device.…show more content…
They should advice about the same with the QA, Production team and Management before the implementation. The challenge here is to monitor any changes related to the device regulations. This is an issue, when the RA department is outsourced to an external company. The problems faced here are the need for technical expertise to discuss about the regulations and the consideration of the cost factors to implement the new standards and the time that takes for the transition. These issues need to be addressed and discussed with the management authorities to identify the need for the new regulations in the facility and thereby providing adequate training and orientation to the QA, production team and other concerned team about the proposed regulations during the implementation phase.
3) The RA Specialist participates in the Quality and Regulatory compliance programs and are often required to write technical reports based on any test data or for modifying the Standard Operating Procedure of a Medical
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