Risk Management
Risk management is a mandated regulatory requirement and an essential task that underpins all medical device activities, including the development of a medical device. Companies who do not have appropriate systems for analysis and management of hazards and risks will waste time in the preparation of inadequate risk analysis, and will not benefit from the information that can be gained from an efficient risk analysis process.
In order to manage the risks associated with a device, a risk management process needs to identify the medical device hazards, to estimate and evaluate the risk of each hazard occurring, to determine the root cause of the hazard, to define required mitigating actions, to track the mitigations and monitor the effectiveness of the mitigations. The complexity of the risk analysis will be dictated by the medical device classification.
ISO 14971 is the most widely accepted medical device risk analysis standard. Perficio Product Development use this standard along with military standards (MIL-STD-882E) and associated risk analysis tools (FTA, FMECA) to analyse the risks created during the design, manufacturing, testing or use of a medical device.
Perficio Product Development has extensive experience with medical device risk management activities, from initial concept through to commercialisation and can therefore assist your designers with this vital and mandatory aspect of your development program. Completing your products risk analysis with Perficio Product Development will provide you with a regulatory compliant analysis that will also enable you to define specifications for critical materials, manufacturing processes, test criteria and instructions for the use of your medical device.