This procedure package includes three documents:
1. Product Development Procedure
Purpose – The purpose of this (10)-page procedure is to ensure that product is developed in a systematic way, ensuring that risk control measures are incorporated in the design, that all design outputs are verified against specifications and validated against user requirements, and that regulatory and standards requirements are fulfilled.
Scope – This procedure covers design and development of new medical devices, including their packaging and labeling, and to modifications and upgrades of existing devices. This procedure applies from the approval of the initial design.
This procedure is not applicable to research activities that precede design and development…
2. Design Review Meeting Form
3. Design Requirements Matrix
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