Regulatory Product Approval
This workflow template illustrates the end-to-end process of regulatory approval for new products, including compliance-related requirements gathering, internal testing (against requirements), external testing and final product approval/denial of the product by regulatory officials. Purchase and download this template in PDF and Visio (VSD) formats. You can customize it to fit your own organization, or simply use it to better understand the Regulatory Product Approval process.
What is Regulatory Product Approval?
The Regulatory Product Approval process involves coordination between product development staff, compliance and product testing team members and regulatory agencies to gain approval on a new product. The first step in this process is to define, confirm and document all regulatory requirements to prepare for internal testing. Once the product has been thoroughly tested by internal teams, it is prepared for submission to the appropriate regulatory agencies. If the product is approved by the regulators, preparation for full-scale manufacturing/production begins.
Download a Sample Regulatory Product Approval
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