Align Your Clinical Claims with the Clinical Investigation Performance and Safety Endpoints

FREE ON-DEMAND WEBINAR
October 31, 2023

Align Your Clinical Claims with the Clinical Investigation Performance
and Safety Endpoints

The EU MDR requires that medical device manufacturers are able to clearly identify and collect clinical data that supports their market claims. Similarly, both the FDA and the Notified Bodies are focused on the traceability between clinical claims and the clinical benefits.

The assessment done by the authorities can shift the way that they look at the evidence that a manufacturer must provide to obtain market approval.

During this webinar we will focus on how to address this topic in an analytical way and determine both benefits and risks, align this assessment with the actual collection of evidence and get you on track with the expectations from the authorities.

Watch for free

After this presentation you'll be able to:

Identify your clinical claims within safety and performance
Distinguish safety and performance claims from other claims
Make sure you collect relevant clinical data during the different activities
Identify the risks associated with the specific device
Identify the clinical outcomes of relevance
Wrap up your analysis in benefit risk assessment.

Who should attend?

Clinical Affairs Professionals and Management
Clinical Operations Professionals and Management
Regulatory Professionals and Management

Hosted by

Moderator:
ETIENNE NICHOLS

Medical Device Guru,
Greenlight Guru

Speaker:
HELENE QUIE

CEO,
Qmed Consulting

About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

About Qmed Consulting

Founded in 2006 by Helene Quie, Qmed Consulting is a full-service Contract Research Organization (CRO) based near Copenhagen, Denmark. We provide strategic consulting services in connection with device approval in Scandinavia and internationally through our global alliance.

The driving force behind Qmed Consulting is our commitment to clearing the path for new medical devices and new ideas based on project management, best-in-class expertise in clinical trials, clinical development, regulatory affairs, quality management and commercial healthcare.

When you partner with Qmed Consulting, you acquire direct access to our team of highly skilled professionals. Our team has more than 100 years of experience working in the field of medical device and IVD approval.

Visit their website to learn more.

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