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ISO 14155:2011

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.

Regulatory

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.

Brexit

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.

Case Study

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.

By the Numbers

150 Device Development Specialists
3 Decades of Device Experience
500 Device Trials in the Past 5 Years

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Hello Device

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.

TESTIMONIAL

“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

Covance Insights

Integrated Medical Device and Diagnostics Solutions
Integrated Medical Device and Diagnostics Solutions
Info Sheets
Whether you're developing a medical device or an in vitro diagnostic product, you now have access to an innovative approach that integrates your development journey from concept through post-market support. A cohesive model that enables you to obtain the answers you need to satisfy all your stakeholders - investors, regulators, payers, providers and patients. A cohesive solution brought to you by the dedicated Medical Device and Diagnostic Solutions group of Covance, the contract research organization (CRO) of LabCorp.
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Virtual Tour of Experimental Surgery and Surgical Training Site for Medical Device Development
Virtual Tour of Experimental Surgery and Surgical Training Site for Medical Device Development
Videos & Webinars Play Video
Take a virtual tour of our AAALAC-accredited research facility specifically designed for experimental surgery and training to support medical device development. Four OR surgical suites and fit-for-purpose meeting space can accommodate both large and small groups, conveniently located in the San Francisco Bay area.
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Are You Ready? Impact of Upcoming Regulatory Requirements on Combination Product Reporting
Are You Ready? Impact of Upcoming Regulatory Requirements on Combination Product Reporting
Blogs
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
Little Advisor for Investigators -- ISO 14155:2011 Medical Device Trials
Little Advisor for Investigators -- ISO 14155:2011 Medical Device Trials
Brochures
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

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