Improvement General: The manufacturer shall identify and implement any changes necess ...

. Registration of medical device testing laboratory (1) Before grant of registration ...

Analysis of data The manufacturer shall establish documented procedures to determine, ...

Registration of medical device testing laboratory (1) Before grant of registration to ...

5.2 Customer focus Top management of the manufacturer shall ensure that customer requ ...

The parameters for classification of in vitro diagnostic medical devices as follows: ...

(f) the applicant shall provide for isolation of sick animals as well as animals unde ...

5.6 Management review 5.6.1 General: Top management shall review the organization's q ...