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 SMART-TRIAL by Greenlight Guru, 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

GG_ST_Proxima CRO Webinar 12-15-22
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

Etienne Nichols

Medical Device Guru & Community Manager,
Greenlight Guru

Páll Jóhannesson headshot
Páll Jóhannesson

Co-founder & Managing Director,
SMART-TRIAL by Greenlight Guru

Stephanie Mull headshot
Stephanie Mull

Senior Director of Clinical Operations,
Proxima CRO

ST by GG LOGO Digital - MEDIUM

About SMART-TRIAL by Greenlight Guru

SMART-TRIAL by Greenlight Guru is the only Electronic Data Capture (EDC) platform designed for Medical Devices & Diagnostics, serving as the ideal solution for clinical data collection and clinical project management, monitoring, data management, and statistics. SMART-TRIAL by Greenlight Guru is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.

Learn more →

Proxima CRO Logo + Tag  - Blue - Liz Abide

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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