April 18, 2023 Design & Development Includes Regulatory Submissions Premarket regulatory submissions [e.g., U.S. FDA 510(k) / PMA; European Technical Documentation Submissions, Canadian Device Licensing, Australian ARTG registration, etc.] need to be driven by, and documented in association with, the design and development process and documentation. For example, both the FDA (via the QS […]
<h1 class="entry-title">Category: Design Change</h1>
DHF Documentation of Design Changes
March 13, 2023 DHF Documentation of Design Changes Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF). Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF. Accordingly, if your system does […]