 A firm, which specializes in helping clients through the product safety and international regulatory processes (FDA 510(k), CE Mark, Canadian Medical Device Regulations (CMDR), etc.). The firm specializes in Medical, In Vitro Diagnostic, and high tech devices. Assistance to clients is provided with a team of experts in the interface with the Safety Agencies and Regulatory Bodies, preparing the product for testing, support is also provided in many aspects to obtain FDA 510(k) approval, CE Marking and CMDR including preparation of technical files, training on the product safety standards, directives and quality standards, risk management, assisting companies in developing international standards, and creation and implementation of quality systems. |
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