All medical devices need to minimise the risk of harm to the patient, user or intermediate handler and the risks of using a medical device need to be outweighed by the benefits it will bring.
This covers all aspects of the development of a device from concept through development, into manufacture and once it is provided to the end user or patient.
A risk management plan is generated for all projects undertaken by Europlaz, to ensure that all risks within a project are identified, managed and suitably mitigated.
Specific processes are analysed using Failure Mode and Effect techniques Analysis (FMEA) which systematically review the process and provide a feedback loop which is used to identify, reduce and control risks.
Risk management is best undertaken with a full understanding of the device and the processes used to manufacture the device.
To achieve this Europlaz will converse with your risk management team to provide specialist technical knowledge on the activities we undertake and to gain your insight into your product when carrying out our internal risk management for your product.
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