Best Medical Device Risk Management Consultant for 2023

 Medical devices have caused so many patient deaths and over a million injuries in the past decade. A qualified medical device risk management consultant can help you resolve safety issues and, ideally, remove your anxiety that your products could harm the end user.

Risk management is an important part of the medical device product development lifecycle. It helps medical device manufacturers to ensure that the final product is reliable, works as expected and causes no harm. The main purpose of the risk management process is to reduce or mitigate the chances of failure in the product.

IZiel’s Expertise

IZiel Healthcare has the expertise to write risk management procedures as per ISO 14971 and then create or restructure the risk management file as per the established procedures. IZiel Healthcare has broad experience creating risk management files from simple (Class I) to complex (Class III) medical devices. Our team uses the following tools to identify the risk associated with the medical device:

·         Preliminary Hazard Analysis

·         Failure Mode and Effect Analysis (Design and Process)

·         Hazard Analysis

·         Fault Tree Analysis

With the use of the above-defined tools, IZiel identifies, evaluates and controls the risk associated with a medical device to the patient, user and environment.