Why off-label data should not be ignored

Use it or lose it: Why off-label data should not be ignored! Danielle Giroud and Erik Vollebregt discuss the challenges and opportunities of using off-label data to expand the intended purpose of a medical device under the MDR.

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Defining your claims under MDR: Turning safety claims into clinical endpoints on CE-mark studies

Question: How do you go about turning safety claims into clinical endpoints on CE-mark studies?

MD-Clinicals’ Danielle Giroud and Renata Nogueira explore the aspects of quantifying safety claims in this insightful discussion bringing the specifics behind defining your safety claims under MDR.

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Current experience update of remote monitoring in SE-Asia

Remote monitoring, when applied under a risk management process in the planning of a clinical investigation, can be a useful tool in addition or in lieu of onsite-monitoring. Although early experience showed some resistance which gradually went away with forced remote activities during the pandemic, we see that with the necessary flexibility in applying tailormade solutions for the sites, remote monitoring becomes a quite appreciated monitoring solution. Ivon Septriyana provides some tips and tricks on applying remote monitoring in SE-Asia studies with medical devices.

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Clinical Development Plan

Is the Clinical Development Plan a mystery for you? Let us help you solve it! Join Danielle Giroud and Namrata Upadhyay as they sit down for a revealing discussion on the medical device Clinical Development Plan - its purpose and intent, and the minimum requirements in order to effectively establish this important section in your CEP.

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Implementing Remote Monitoring - Save Costs and Meet Deadlines!

Risk-based monitoring including remote monitoring, is an approach that has been successfully applied now for many years. With increased requirements for conducting post-market clinical follow-up studies and registries, how can monitoring be optimized so you continue to ensure compliance and accuracy of data that will be accepted by the notified bodies or regulators while keeping costs reasonable?

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Risk Management for Medical Device Clinical Investigations

Join us for this fascinating series of in-depth discussion, analysis, and expert insight on Risk Management for Medical Device Clinical Investigations presented by renowned industry experts, Danielle Giroud, Dr. Maria E. Donawa, and Dr. Bassil Akra.

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Global Medical Device Focus 2021

From concept to market access. From South America to Asia. Discover the essentials that make medical device success a reality!

Come join the medical device industry's leading experts and authorities in global clinical research and regulatory affairs for an exciting program of discovery and exchange. With a diverse array of topics and discussions to choose from, there's something for everyone at the Global Medical Device Focus 2021. This great opportunity will help participants learn what it takes to successfully plan, implement, and obtain successful medical device registrations throughout various countries and regions around the world.

Webinar session recordings are now available on the WMDO platform. Click on any of the links below to watch: