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.
Over the last few weeks, this blog has explored the components of risk management and how it is a key component to quality management systems. But what about potential risks and the best practices for manufacturers to follow?
The first step all manufacturers should take is to identify any hazards that may occur due to characteristics or properties of the medical device during normal usage or foreseeable misuse. Criteria for determining acceptable risk levels must be established and implemented. Why? After hazards are identified, risks are evaluated, deemed acceptable or unacceptable, and need to be addressed based on a set criteria. These hazards may be pulled from a variety of sources, including:
As thorough identification of hazards is difficult, ISO 14971 provides a number of aids, including Annex C which provides device characteristics that may impact safety, and Annex H which provides information on in vitro diagnostic devices.