IMPLEMENTATION OF RISK MANAGEMENT FOR MEDICAL DEVICES

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MANAGEMENT RESPONSIBILITY

ISO 14971’s management responsibility directive states that management is responsible for

developing an “Acceptability Policy” – taking into account international standards and local (regional) regulations.
Management is also responsible for providing adequate resources.
Assigning trained personnel
And reviewing the results of risk management activities at defined intervals through the process.

QUALIFICATION OF PERSONNEL

The manufacturer is responsible for ensuring that personnel with knowledge of the risk management task have experience and knowledge of the medical device including the application and use of that device.

RISK MANAGEMENT PLAN

The plan is a component of the risk management file and includes:

The scope of the plan
A verification plan
Allocation of responsibilities
Risk management review activities
Risk acceptability criteria
- A note on acceptability criteria: this is usually assisted by way of looking at the company’s history with similar devices, looking at devices already on the market (competitor’s devices), and/or looking at what the alternatives are (other therapies).

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