Pharmaceutical and Medical Device Testing, Engineering Services, Regulatory Assistance, and Manufacturing Support

 
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ISO 10993 BIOCOMPATABILITY TESTING

Biocompatability of the materials used for manufacture of any medical devices is a very important variable in the analysis of safety, and is a particularly sensitive issue with the FDA. Although in the past the FDA accepted USP testing, this is no longer the case. Actual testing required is dependant on both the level of contact and the duration of contact. Piper Medical can provide the unbiased, quality data and analysis necessary to meet your product objectives. If your testing requirements are part of a larger FDA regulatory strategy, our extensive experience with the FDA can make your job easy.

For answers to your questions, contact us.