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Hi, I need some advice can you help? I seem to be swimming against the tide here!
We have a product development team which bring new products to the market place. Some of these products are not medical devices, but they are used by customers who work to GMP and expect a high degree of conformance to all relevant standards and GMP.
I say, that we need to perform risk analysis for all products brought to the market place irrespective of whether it is a medical device or not.
I have read the standard, I believe that this is the intent of the document, others in the organisation believe I am just trying to slow down the process. I say it is a requirement (and good business practice), and I'm just trying to eliminate potential problems.
I would welcome a healthy discussion / debate - if I'm wrong - then that's ok, but why?
We have a product development team which bring new products to the market place. Some of these products are not medical devices, but they are used by customers who work to GMP and expect a high degree of conformance to all relevant standards and GMP.
I say, that we need to perform risk analysis for all products brought to the market place irrespective of whether it is a medical device or not.
I have read the standard, I believe that this is the intent of the document, others in the organisation believe I am just trying to slow down the process. I say it is a requirement (and good business practice), and I'm just trying to eliminate potential problems.
I would welcome a healthy discussion / debate - if I'm wrong - then that's ok, but why?