PIQ obtained ISO13485 certification in Apr 2021.
Manufacturing for the scale-up was transferred to Biotem and Abcam who are both also ISO13485 certified.
Validation and Verification- no news yet.
I guess that the full FDA will be completed once validation has occurred according to the March 2022 qtrly.
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PIQ obtained ISO13485 certification in Apr 2021. Manufacturing...
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