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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
SEPTEMBER 8, 2022

Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)

Innovate smarter and not harder by taking key considerations including when an AI solution may be needed and identifying appropriate research questions and best practices for engineering and deploying the model effectively based on industry and the FDA’s SaMD (Software as a Medical Device) regulation guidance. 

Join Proxima Clinical Research’s subject matter expert, Director of Regulatory Affairs, Isabella Schmitt, MBA, RAC, who will expand on clinical considerations for software and artificial intelligence (AI) and machine learning (ML). For all of those interested in learning about this timely topic, register for this free, in-depth webinar now!

Watch the webinar
Proxima CRO webinar 9-8-22
Specifically, this webinar will cover:
  • Valid clinical association, analytical validation, clinical validation, and good machine learning practices 
  • Practical implications software developers should be aware of that range from ethical concerns about algorithmic bias to legislative concerns 
  • Circumstances when an AI solution may be needed and identifying appropriate research questions
  • Best practices for medical device engineering and deploying the model successfully based on the MedTech industry and the FDA’s SaMD regulation guidance
Who should attend?
Innovative MedTech companies Register Now  

Hosted by

Isabella Schmitt
Presenter: ISABELLA SCHMITT, MBA, RAC

Director of Regulatory Affairs,
Proxima Clinical Research
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Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

 

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About Proxima Clinical Research

Proxima 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 

Visit their website to learn more.


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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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