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Medical Products

Thursday, March 8th, 2018

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Posted in General | Comments Off on Medical Products

qCompetence recommends: request management for medical products with the help of risk management for product development and approval of medical devices is the requirements management and requirements engineering (E.g. specifications) as essential as risk management. Risk management is the recognition and proper inspection of product risks, which in turn affects the requirements management. The question is always: what is the goal of my project or product? What must be able to my product? What needs / requirements my customers or what legal requirements have to be implemented? The risks associated with the use of my product? They identified fully and comprehensively? Defined the appropriate risk reduction measures? How big is the cost resulting from the risk of a product? Can this be adequately controlled? But back to the starting point of the question for the right\”requirements. The problem is almost always, as interest groups with their respective Requirements to take into account adequately. The catalogue should be understandable, usable and clearly designed. This is possible in relation to the development of complex medical devices not always readily.

A solution is to divide the total product and project modules. This changes in requirements on defined areas are limited = module. Which in turn would facilitate the maintenance of the requirement profile or change management requests very. As well, the communication between the parties involved in the product development could be implemented better. However, other challenges are thus not yet been resolved. \”Often are many stakeholders involved in a project, coming from different areas and different\” languages. \”This language describes easy and in the form of user stories\” the everyday \”benefits of a medical device for the user, such as a doctor or a nurse. That’s why is a language for the description of Necessary, understand all requirements. That is, the language is colloquial rather than technical, it is pictorial and works with analogies, its content, is qualitative and not quantitative.