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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.