Training FDA regulations for medical devices

Mikrocentrum

The FDA regulations training for medical devices teaches you how to comply with the American FDA requirements regarding the effectiveness and safety of medical devices. Check out the training!

Price

from €1,995

Level

Not specified

Kind

Training

Subject

Health and safety

More information and registration at Mikrocentrum

Description

The United States has the largest market for medical devices worldwide. This is where the FDA and the Food & Drug Administration come into play. They set specific requirements regarding the effectiveness and safety of medical products. The practical training on Market access for medical devices according to FDA regulations teaches you how to bring a medical product to market in the US. Discover the requirements for electronic records, software and process validation, medical device reporting, recalls, and Quality System Inspection Technique (QSIT guidance). Learn to work according to the Quality System Regulation (21 CFR 820). Understand the regulations and guidance for risk management.