Adis whitepaper

Whitepaper: The changing faces of device safety

The benefits of literature monitoring throughout the lifecycle

Executive Summary

One would be forgiven for thinking that the current changes to the guidelines for medical device safety meant just an increase in workload for the manufacturers. But look beyond the “overalls” and you will see that these changes present a golden opportunity for the device industry to demonstrate the real-world benefits it has on our ever-increasing, but ageing global population through its products. A population that is more readily accepting
of and actively seeking mechanical and electronic solutions for a healthy lifestyle than any generation that has gone before.

What follows, highlights the benefits of proactive literature monitoring for evidence of device performance in the real world. It demonstrates how gathered data can not only aid compliance with regulatory requirements, but may also help cut costs and time going into market. And, more importantly, help gain an edge over competitors in this congested space, and positive interest from payers, once the device is on the market.

Enlisting expert help with literature monitoring and data gathering will ease the burden, leaving manufacturers free to be creative and successfully competitive in the dynamic medical devices market.


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