Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Risk management principles shall be applied to the life cycle of medical devices. But why? These principles must be applied in order to maintain pace with changes in technology and to better address safety issues arising from age, intended use or foreseeable misuse, work environment, and production (or post-production) complaints.
There are three phases that comprise the risk management process. Each of these phases should be performed in the following order and repeated throughout the lifecycle of the device as new hazards are identified:
The Risk Analysis and Risk Estimation phases are commonly referred to as the Risk Assessment.
The results of all three phases shall be recorded in the Risk Management File.
On June 20, this blog will explore the importance of how a company's quality team needs to work in tandem with the engineering team for RMF requirements in Third Edition.
To learn more about Third Edition and or to speak with an Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com.