US FDA Certification Consultant For Medical Devices:
In US, the US FDA regulates the sale of medical devices. There are different regulatory controls for devices of different classes. For class I devices & some 510(k) exempted devices , there is establishment registration & device listing. USFDA Certification Consultant and USFDA Registration consultant for medical device manufacturers Industry.
USFDA Registration Consultant services For Medical Devices:
Operon Strategist classifies the Medical devices & gathers information about the company the products which is then uploaded through an online process. Operon Strategist helps clients develop an appropriate regulatory pathway. We study the product, its intended use, its classification, & gradually build a workable regulatory pathway.
For class II devices, there is a process called the 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence. Operon Strategist helps client in classification of the device after consultation with the client. Thereafter, the 510(k) process is explained & the scope of work is explained.