Medical device manufacturers must play an active role in monitoring user’s experiences with their device after launching their product. It is the manufacturer’s responsibility to systematically gather, record and analyse data about the quality, performance and safety of their medical device. Using this data, the manufacturer must investigate any issues and immediately respond to any potential or known adverse events. These activities are collectively known as Post-Market Surveillance (PMS) and it’s something we at BlueBridge Technologies excel at.
Monitoring Users’ Experiences
Ensuring Devices are Safe and Effective
An established post-market surveillance system is necessary to manage these activities. On-going data collection and analysis is required to continuously ensure that your device is safe and effective for use. This analysis might involve the detection of a fault in the field. Alternatively, trend analysis might expose a potential or imminent fault that can be corrected before any adverse event occurs. If a corrective action or preventative action is identified, the manufacturer must take the appropriate measures and notify the relevant regulatory entities within strict timeframes. Post-market surveillance also provides you with a vehicle to identify characteristics about the device that can be improved upon and can be valuable in contributing to clinical evaluations.
Why Companies Choose BlueBridge Technologies
Establishing, maintaining and actioning a post-market surveillance system can be a daunting task. However, at BlueBridge Technologies, we leverage decades of experience to perform post-market surveillance activities that are custom tailored to any given medical device. We maximise the data gathered, efficiently analyse the findings and professionally handle all the reporting needs. Working with us, you can have confidence that the complex regulatory PMS requirements will be superlatively met.