Writing Test Procedures for Medical Devices

tantan · Jul 21, 2009

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!

alex.Kennedy · Jul 21, 2009

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

Nissim Shaked · Jul 26, 2009

You can use the attached example
as a very good reference:
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052487.pdf
(Originally intent for the drugs sector)

Ajit Basrur · Jul 26, 2009

tantan said:
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.

Writing Test Procedures for Medical Devices

tantan

alex.Kennedy

Nissim Shaked

Shaked

Ajit Basrur

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