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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 VIRTUAL SUMMIT:
November 1-2, 2022

The Future of QMS Requirements True Quality Summit Series

If you don’t have a world-class Quality Management System, you may be falling behind. Your QMS can go beyond compliance as you work to enable a culture of True Quality. With QMS requirements changing, it’s important to understand how this will impact your business and product.

In this True Quality Summit Series, we’ll spend two days diving into the future of QMS requirements. Learn about upcoming deadlines, new changes, and what you can expect as you work towards a world-class QMS.

Sessions

Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance | Francisco Vincenty

ISO 13485: What's Next? | Chandler Thames

Moving up to the State of the Art in Risk Management | Ed Bills

eMDR Program and Process | Alireza Hemmati

Modernizing your QMS to keep up with the Modern Age of Requirements | Ben Bancroft and Radhika Pandya

QMS from a Regulatory Perspective | Carmen Brown

QMSR Harmonization: The Future of FDA's Quality Management System Regulation | Dr. Deepa Pandia

Common Misconceptions on Medical Device Risk & Design Controls | Rob MacCuspie

Watch the Summit Series
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Specifically, this summit series will cover:
  • Ensure your QMS is compliant and meets the updated requirements in evolving areas like risk management, Computer Software Assurance (CSA), ISO 13485, and more
  • Understand key deadlines, updates, and dealbreakers that are necessary for you to get (and keep) your devices on the market
  • Learn how to move away from paper-based approaches and build a QMS that scales
  • Think proactively about what new threats the medical device industry may have to address in the future
Who should attend? 
  • Medical Device Executives & Leadership Teams
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
 Register Now  

A few of the experts...

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Francisco Vincenty

Case for Quality Program Manager,
FDA

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Dr. Deepa Pandia

NAM Auditing Department Manager,
TÜV SÜD

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Alireza Hemmati

Senior Product Assessment,
TÜV SÜD

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