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In this booklet, you will find requirements described in the ISO 14155:2011. The ISO 14155:2011 defines requirements to protect the rights, safety and well-being of human subjects; to ensure that the results of a clinical trial are credible; to confirm the scientific conduct of the clinical study; and to specify the responsibilities of the ethics committees, regulatory authorities and other bodies involved in the clinical trial as well as the responsibilities of the sponsor and the investigators. Compliance with ISO 14155:2011 is an essential contribution to the overall trial success.Read More
Combination Products: What are they? Any product formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.Read More
How could a no-deal Brexit affect my medical device lifecycle? EU and GB flags togetherConsiderable uncertainty surrounds Britain's imminent exit from the EU, and it is possible that there could be a "no-deal Brexit" scenario.Read More
A startup company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition. Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small. But by correctly classifying the device, time to market was minimized.Read More
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It is an exciting time for medical device and diagnostic development. Innovations such as AI, robotics, mobile/ home-health, apps and combination products are transforming healthcare. Advances so forward thinking that they are out-pacing today’s regulatory environment.
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