What is this published document about?
Experience shows that manufacturers have difficulty with the practical implementation of some clauses in the medical devices risk management standard BS EN ISO 14971. This published document is the UK implementation of an international Technical Report. It supplies guidance on tackling specific clauses in the standard.
Who is this published document for?
- Medical device manufacturers
- Regulators
- Other users of BS EN ISO 14971
Why should you use this published document?
This is not an overall guidance document on the implementation of BS EN ISO 14971, but it will help manufacturers in the development, implementation and maintenance of risk management for a wide variety medical devices including: active, non-active, implantable and non-implantable devices and in vitro diagnostic devices.
It provides guidance to help manufacturers and other users of the standard:
- Understand the role of international product safety and process standards in risk management
- Develop the policy for determining the criteria for risk acceptability
- Incorporate production and post-production feedback loops into risk management
- Differentiate between information for safety as a risk control measure and disclosure of residual risk
- Evaluate overall residual risk It also supplies insight into the different approaches an organization can use to implement and maintain aspects of a risk management system that conforms to BS EN ISO 14971.
