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ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.
This online training also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services
Lesson 1: Whats is a medical device ?
Lesson 2: What is a quality management system ?
Lesson 3: What benefits will it bring to my organization ?
Lesson 4: Why was ISO13485 revised ?
Lesson 5: What are the key improvements ?
Lesson 6: I am certified to ISO 13485:2003, what does it mean for me ?
Lesson 7: Relationship with ISO 9001