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Regulatory Requirements Do Not Prevent Integration of Lean and Agile Methods into Medical Device Product Development

Lean and agile are frequently used terms in product development.  The advantages of these techniques to improve time to market are well known.  Some medical device companies feel that lean and agile techniques cannot be used because of design controls.  However, the regulations don’t prevent the use of those techniques during product development. In the…
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One World, Different Perspectives of Product Development

There is surprisingly little overlap in the various communities involved in product development. This article describes some of the differences in perspective….
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Agile Methods in Medical Device Product Development

Medical device product development is different from other industries, so is it ok to use agile methods? …
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