Writing Test Procedures for Medical Devices

T

tantan

#1
Hi, Just wanted to get some feedback regarding writing of procedures for medical devices. At the moment all the final inspection test procedures are presented in a table, with line items indicating the method, acceptance criteria and instruments. Within the inpsection method, reference is made to a relevant standard i.e 10993 as the test method. I am more of the opinion that each test method should be written out seperately and in its entirety, and the table just references each individual test method. I am also of the opinon that even if a test method in a standard is used such as ASTM or ISO it should be written in its entirety, but referncing the applicable standard...I say this because lots of standards don;t detail all aspects of the test or there may be slight variations. If anyone can give feedback as to whether this is the right approach I would really appreciate the feedback! Thanks!
 
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A

alex.Kennedy

#2
Hi
It sounds as though you are doing all the right things. The regulators want to see that for each test or at times groups of tests there is:
1/ A rationale; why the test is required.
2/ An acceptance criteria.
3/ A test method.
4/ A test result.
They do not want to see ticks. they expect each test (sometimes groups) to be signed or at least initialled and dated.

Regards
Alex Kennedy
 
Last edited by a moderator:

Ajit Basrur

Staff member
Admin
#4
Hi, Just wanted to get some feedback regarding writing of procedures for medical devices. At the moment all the final inspection test procedures are presented in a table, with line items indicating the method, acceptance criteria and instruments. Within the inpsection method, reference is made to a relevant standard i.e 10993 as the test method. I am more of the opinion that each test method should be written out seperately and in its entirety, and the table just references each individual test method. I am also of the opinon that even if a test method in a standard is used such as ASTM or ISO it should be written in its entirety, but referncing the applicable standard...I say this because lots of standards don;t detail all aspects of the test or there may be slight variations. If anyone can give feedback as to whether this is the right approach I would really appreciate the feedback! Thanks!
I agree with you .... write the full method as a "Test Procedure" rather than simply referring to the standards. You could use the standard no as a reference to show where it originates from. :)
 
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