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Medical Device and Diagnostic Solutions

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EU MDR and IVDR implementation and deadlines - Proposal for EU MDR application delay

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.

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Are You Ready? Impact of Upcoming Regulatory Requirements on Combination Product Reporting

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.

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How a No-Deal Brexit Might Affect Medical Device Development: Legal Consequences and Risk Mitigation Strategies

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.

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Avoiding Market Access Delay Due to Incorrect Product Classification Case Study

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.

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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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“With deep experience of drug, device and diagnostic development, and a complete suite of regulatory, quality, health economics & reimbursement, surgical prototyping, biocompatibility testing and clinical trials, education and patient safety services, Covance is uniquely positioned to help you realize the full potential of your product.”

Suzanne Carroll
Vice President, Covance Medical Device and Diagnostics

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