Dynatec now offers consulting services regarding ISO 14971. How to perform Risk Analysis of your product, in meeting F.D.A.’s requirements for medical devices.
Dynatec now offers applied chemistry in the design of “Tolerable Contact Limits” for your medical device. In addition, Dynatec can perform Chemical Evaluation on your medical device to identify hazards and estimating biological risk as key factors in a comprehensive Biological Safety Evaluation Plan for your product.
Dynatec now performs Cytotoxicity in accordance with ISO 10993-5, 10993-12, USP :
* Direct Contact
* Agar Overlay