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Using ISO 13485 to manage process validation in the medical device manufacturing industry
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods...
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods stage. Industrial processes in medical device manufacturing facilities convert raw materials into semi-finished materials, and...
How to manage the medical device sterilization process according to ISO 13485:2016
Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical...
Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical devices are not properly sterilized. As a result, many patients die, while many more are...