Understanding and engaging in the risk management process for medical device manufacturing is an important point that has to be considered not just by the devices manufactures but by the suppliers also. The survey showed a limited knowledge by suppliers, in particular, of the ISO 14971 standard. Suppliers must not only be familiar with this standard, but should work proactively with their customers as part of the Risk Management process. For example, changes in processes should determine if the screening and testing should be reviewed; changes in manufacturing locations should also be assessed and communicated as an inherent part of the process.
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