Medical Device

Product & Process Documents:
roduct documents describe the specific attributes, design, and characteristics of a product. They focus on defining what the product is, its components, design specifications, and the necessary information required for production, evaluation/testing and support.

Features of Lean Design Documents:
Lean design documents are intentionally structured to ensure clarity, conciseness, and the elimination of waste. They provide precise yet complete information to support design, manufacturing, and validation processes. Let’s take a look at some examples and additional attributes of Lean Design in action:

Role of The Design History File:
The Design History File (DHF) is vital for documenting the design process, particularly in regulated industries such as medical devices, to ensure products meet safety, quality, and regulatory requirements.