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Monthly Archives: August 2017

How to Use ISO 14971 and Project Risk Management Effectively

Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well. What is Project Risk Management The PMBOK Guide[i] defines risk as “an uncertain event or condition that, if it occurs, has a positive or negative effect […]

Get small to improve time to market

Small batches will help you improve time to market, read the difference between the traditional and non-traditional approach to product development below. Traditional approach to product development (Batches of major activities) In a traditional phased-and-gated system, each phase is a batch of activities that has to be completed in order to produce a set of […]

Another reason for product failure

What can you do while developing a product to maximize its chances of success?

How to Identify and Manage Product Development Risk

Project risks come in many different forms, from those the project team anticipates to the ones they discover when an unexpected problem crops up. In product development, there are many sources because you interact with so many parts of the organization in order to commercialize the product. Learn how product development risk and project risk […]

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