Project Description

We are into design, manufacture and marketing of medical products that are used by healthcare establishments. We need FDA GLP and ISO Laboratory for biocompatibility tests for our medical product in your esteemed laboratory as per standard ISO 10993 (Biological Evaluation of Medical Devices). We are using silicon rubber as a raw material for our finished product fall under the category of surface contact (skin), and contact time of duration is limited (likely up to 24h) or sometimes goes to "prolonged" (between 24 hours to 30 days). Contrary to aforesaid ISO requirement, we would like to do the following tests;

1. Invitro cytotoxicity as per "ISO 10993-5:2009"
2. Skin sensitization as per "ISO 10993-10:2010"
3. Irritation or intracutanious reactivity as per "ISO 10993-10:2010"

Please send us the quote for both methods GLP & Non-GLP as soon as possible along with details of your laboratory accreditation.

Looking forward to hearing from you.

Regards

S. Subramaniam