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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

2023-10-11T04:45:03

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(v) details of competent technical staff, under whose direction and supervision the sales ...

2023-08-29T04:36:52

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3. Procedure for audit: The notified body shall carry out the audit in the following manne...

2023-09-11T05:05:00

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Medical Doctor (MD) License: Medical doctors, also known as physicians or doctors of medic...

2023-10-21T04:48:25

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

2023-10-09T05:45:47

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3.16 Rework means action taken on a non-conforming product that will fulfill the specified...

2023-10-09T05:44:44

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3.13 Quality audit means a systematic, independent examination of a manufacturer's quality...

2023-10-09T05:43:46

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3.8 Design output means the results of a design effort at each design phase and at the end...

2023-10-09T05:41:57

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1.2 Information regarding sterilization of the device (whether it is sterile or non-steril...

2023-09-13T05:06:07

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