5 Tips for Designing a Medical Device Study under US FDA Requirements

FREE ON-DEMAND WEBINAR
December 15, 2022

5 Tips for Designing a Medical Device Study under US FDA Requirements

Medical device clinical studies often present unique challenges for companies, and starting off on the wrong foot can send device manufacturers down a path of high costs and low quality results.

Following best practices when designing a clinical study will not only set manufacturers up for a successful study with fewer constraints and lower costs, it will also ensure sufficient, high-quality GCP compliant data that eases FDA submissions and boosts market success.

But how do you get started on the right foot, and what are some of the key considerations before moving forward with your clinical study design?

Register for this free webinar presented by clinical data expert and co-founder of Greenlight Guru Clinical, Páll Jóhannesson, and senior director of clinical operations at Proxima CRO, Stephanie Mull, who will provide you with key insights on medical device study design and planning that you can implement right away.

Watch the webinar

Specifically, this webinar will cover:

Overcome common pitfalls of clinical study planning and design
Optimize clinical study resources and reduce costs
Site selection and safety management considerations
Produce higher quality clinical evidence with less constraints
How to work with a Contract Research Organization (CRO)

Who should attend?

Clinical employees of small to medium sized MedTech companies Register Now

Hosted by

Moderator:
Etienne Nichols

Medical Device Guru & Community Manager,
Greenlight Guru

Presenter:
Páll Jóhannesson

Co-founder & Managing Director,
Greenlight Guru Clinical

Presenter:
Stephanie Mull

Senior Director of Clinical Operations,
Proxima CRO

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 website to learn more.

About Proxima CRO

Proxima CRO works with emerging biotech and medical device companies across all phases of development. As a contract research organization, we organize our team in two distinct areas: early stage advisory consulting and all-inclusive clinical trial services. The service you need. The speed you want. The attention you deserve.
- Early Consulting
- Regulatory Consulting & Communicating With FDA
- Clinical Study Planning
- Study Execution
- Reimbursement & Market Access

Learn more →

About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success. 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.

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5 Tips for Designing a Medical Device Study under US FDA Requirements