hi everyone,
Can you please help me about AAA LAC requirement to do our product testing.
My Director told me we dont need to do our product testing in AAA LAC lab because our product is only class 1 (like urine specimen container, sputum cup).
is there any directive of letter for me to give to my Director so that i can support and comply to our Auditor requirement to all our product to do test (Biocompatibility tests).
need your opinion pls.
*the reason my boss said that we only sold our product locally(Malaysia) so the is no evident that we need to do a test in AAA LAC lab. arcoding to Malaysia medical device act 737.
Can you please help me about AAA LAC requirement to do our product testing.
My Director told me we dont need to do our product testing in AAA LAC lab because our product is only class 1 (like urine specimen container, sputum cup).
is there any directive of letter for me to give to my Director so that i can support and comply to our Auditor requirement to all our product to do test (Biocompatibility tests).
need your opinion pls.
*the reason my boss said that we only sold our product locally(Malaysia) so the is no evident that we need to do a test in AAA LAC lab. arcoding to Malaysia medical device act 737.