How to Use Clinical Data for Medical Device Submissions in both EU & US

FREE ON-DEMAND WEBINAR
January 17, 2023

How to Use Clinical Data for Medical Device Submissions in both EU & US

Generation of clinical evidence for medical devices is highly impacted by local regulations.

Device manufacturers must be on top of regulations in all relevant markets before generating clinical data.

An important point that many realize too late, is that clinical data collected in medical device studies in Europe cannot be used for FDA submissions and vice versa - unless certain requirements are fulfilled.

Having this in mind when generating clinical evidence can help manufacturers to avoid launching additional clinical investigations for new markets.

In this free webinar medical device experts from Avania and Greenlight Guru Clinical (formerly SMART-TRIAL) will share advice and insights on how you optimize your clinical strategy for multiple markets and answer common questions, such as:

What type of parallel clinical evidence strategies could you consider when drafting a clinical development plan for multiple markets?

What are some of the local requirements for clinical investigations?

How can you optimize the study design to be useful for multiple clinical submissions?

Watch the webinar

Avania+SMART-TRIAL by Greenlight Guru webinar 1-17-23

Specifically, this webinar will cover:

How it is sometimes valuable to investigate a pre-market study design in one regulatory region, versus a post-market study design in another, combining data into one set of clinical evidence for your product.
Set-up of a clinical development plan for multiple regulatory regions when your product may be at different marketing phases at one moment in time.
Difference in good clinical practice requirements. What to be aware of before launching a study in the US, if you are to use data in the EU too.
How does study sample and design impact your future use of clinical data from a study, for market access?

Who should attend?

Small to medium sized medical device manufacturers with go-to-market aspirations for both US and EU Register Now

Hosted by

Moderator:
Etienne Nichols

Medical Device Guru & Community Manager,
Greenlight Guru

Presenter:
Jón Ingi Bergsteinsson

Co-founder,
Greenlight Guru Clinical (formerly SMART-TRIAL)

Presenter:
Mary Kay Kessinger Sobcinski

Senior Director, Strategic Consulting,
Avania

Presenter:
Kim van Noort

Senior Medical Writer,
Avania

About Greenlight Guru Clinical

Greenlight Guru Clinical is the leading clinical data collection toolbox, purposefully built for MedTech. Collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more.

Greenlight Guru Clinical meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020.

Visit our page to learn more.

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 Avania

Avania is the team that has the regional experience and global expertise to take your product from feasibility all the way through post-approval. Avania is dedicated to driving your product forward. When you partner with Avania, you become part of a company legacy built on more than 30 years of experience.

Avania brings knowledgeable experts together to form a unique CRO that can advance the research of medical devices, novel technology, and combination products. All of this is available across a wide range of therapeutic specialties. This ensures you receive the kind of customized, scalable solutions that will optimize efficiencies and streamline the advancement of your medical technology. And since Avania’s experts are known for providing transparent, open communication, you’ll always have complete project visibility whenever you need it.

Learn more →

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How to Use Clinical Data for Medical Device Submissions in both EU & US