What is meant by documents (or list) of external origin?
Documents of external origin are considered to be regulations, laws, binding and/or applicable regulations, technical standards and any other public or [...]
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20 09 2023
20 09 2023
20 09 2023
Why is it necessary to implement and manage the process of compliance with standards, laws and regulations?
The implementation and management of the compliance process with standards, laws and regulations is necessary to market Medical Devices and IVDs [...]
20 09 2023
20 09 2023
What does the list of documents of external origin depend on?
The definition of which standards, laws and regulations to include in the list of external source documents depends on the regulatory [...]
20 09 2023
20 09 2023
Who controls the updating of documents of external origin?
Documents of external origin are checked by Notified Bodies during CE certification process, by Certification Bodies during ISO 13485:2016 certification process [...]
