SOP Regulatory Strategy
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Use this SOP Regulatory Strategy template to define and document your organization’s approach for bringing medical devices to the US and EU markets, covering device classification, regulatory pathways (such as FDA 510(k), PMA, CE Marking), pre-market, and post-market requirements. Complete and maintain this SOP to ensure regulatory compliance, address evolving requirements, and manage the impact of regulatory changes on your products and processes throughout the device lifecycle. This template is essential for regulatory, quality, and product teams and should be filled out and updated before market entry and whenever relevant regulations are updated.