FDA GMP OBGYN Dilator Device Biocompatibility Testing for FDA Clearance
Project Description
MULTIPLE TESTING
FDA GMP Medical Devices Laboratory needed for FDA Clearance testing on an adjustable dilator for the OBGYN market for biocompatibility of the plastic and silicone.
It is made of stainless steel, acetate plastic and silicone. Dimensions: 7inches x 3 inches x 3 inches. Below is the list of tests we will have to do for our FDA clearance.
Biocompatibility tests :
Cytotoxicity;
Sensitization;
Irritation;
Acute Systemic;
Toxicity;
and Biological Risk.
Please let me know if you can do it and if yes, when can you send me a quotation and for each test? Please show the ASTM reference for each test.
Project Information
Number:23-00908
Industry:Medical Devices
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