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By Marie B. Teixeira

''Design keep watch over is a key portion of a company's caliber administration approach and is remitted by means of the U.S. FDA's caliber approach rules below article 820.30 for many scientific units. scientific machine businesses wishing to conform with ISO 13485 to satisfy foreign standards also are topic to layout keep an eye on requisites. This moment variation of a bestselling ebook expands and updates all chapters with element on Read more...

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By Marie B. Teixeira

''Design keep watch over is a key portion of a company's caliber administration approach and is remitted by means of the U.S. FDA's caliber approach rules below article 820.30 for many scientific units. scientific machine businesses wishing to conform with ISO 13485 to satisfy foreign standards also are topic to layout keep an eye on requisites. This moment variation of a bestselling ebook expands and updates all chapters with element on Read more...

Show description

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Extra resources for Design controls for the medical device industry

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Gantt charts are essentially bar charts that emphasize the time it takes to complete tasks, while PERT charts are flowcharts that emphasize relationships between tasks (especially their dependencies). 22 Design and development planning Gantt charts The Gantt chart was developed by Charles Gantt in 1917. It provides a graphical representation of the sequence of tasks and is an excellent tool for quickly assessing the status of a project. Each task is listed in a column along the vertical axis (y-­axis).

The outcome of this process, that is, feasibility, can then be reviewed by key company personnel so that a decision can be made as to whether the project should move forward into development. Several elements should be included in the concept document: • A statement of product purpose or indication: Why would we want to develop this product? Is there an opportunity? How big is the opportunity, and what are our expectations? • A statement of the market position: How is this product going to compete?

How is it the same? Will a clinical study be required, or will a clinical evaluation be sufficient? • A statement regarding cost: What should the product cost? What does it need to cost? Will it be reimbursed? 1. Once the concept phase is completed, the output from this evaluation/­testing must be evaluated to determine if there is a viable product. If management decides to move forward with the design and development of the product, appropriate approval(s) should be documented, and a design team composed of personnel representing different disciplines should be assembled to prepare the PPS and formally kick off the design and development process.

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