AMC1 ORA.FSTD.240
Record-keeping
ED Decision 2012/007/R
FSTD RECORDS
(a) FSTD records to be kept should include the following:
(1) for the lifetime of the device:
(i) the master QTG (MQTG) of the initial evaluation;
(ii) the qualification certificate of the initial evaluation; and
(iii) the initial evaluation report;
(2) for a period of at least 5 years (in paper or electronic format):
(i) recurrent QTG runs;
(ii) recurrent evaluation reports;
(iii) reports of internal functions and subjective testing;
(iv) technical log;
(v) CMS report;
(vi) audit schedule;
(vii) evaluation programme;
(viii) management evaluation reports;
(ix) obsolete procedures and forms.
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