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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

Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

Effective, well-documented verification and testing activities are fundamental for ensuring your product fulfills the necessary compliance requirements.

When done right, you'll have a high quality product development process with reduced mistakes, fewer changes, and accelerated speed.

Compliance with the IEC standards for medical software and hardware, however, tend to be one of the most common sources of confusion for manufacturers.

Having a clear understanding of the international standards which will dictate your verification and testing activities is the only way to ensure compliance and produce a high quality software or hardware medical product.

We've teamed up with Kyle Rose of Rook Quality Systems who will share his expertise on the topic and provide proven tips and strategies your company can start implementing today to ensure compliance with ISO 13485:2016, IEC 62304/60601/82304.

This in-depth webinar will cover key aspects from these internationally recognized industry standards by explaining them in an easy to understand fashion.

Eliminate any previously held confusion and proceed with confidence with meeting the necessary requirements for your device.

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Some of the changes we will cover include:
  • Discuss what types of medical devices will require verification testing and how to identify what standards your device needs to test to. 
  • Review best practices and common mistakes for IEC 60601 testing for electrical medical devices. 
  • Provide details on the requirements for medical devices containing software and software as a medical device (SaMD) to show compliance to 62304/82304. 
  • Discuss how to capture internal verification testing based on FDA guidance for test protocols and reports. 
  • Review how using a design traceability matrix is essential to ensuring all of the required testing is completed. 
  • Q&A session
Who Should Attend?
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Clinical Affairs Professionals and Management 
  • R&D Engineers and Management
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Hosted by

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Presenter: Kyle Rose

President, Rook Quality Systems
Wade
Moderator: Wade Schroeder

Medical Device Guru, Greenlight Guru

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About Rook Quality Systems

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting 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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