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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

How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File

Risk Management is an integral part of any Quality System, yet companies are struggling to keep up with regulatory updates and the impact on their QMS.

Significant changes in the regulatory climate have shifted to risk-based processes, providing a greater emphasis on the Risk Management files for medical related products.  

ISO 14971:2019 was issued to harmonize those concepts across multiple regulatory bodies and incorporates some significant changes in the existing risk management landscape.  

The processes described in ISO 14971 assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Join internationally esteemed regulatory experts Audrey Prosser and Rebecca Waterbury for an interactive session covering the key changes to ISO 14971 as they give you practical approaches for implementation of the new standard for both new products and legacy products.

Learn about the key updates to ISO 14971:2019 and hear insights from other companies implementing the revised standard. Explore best practices for updating risk documentation and staying compliant with international standards. 

Watch the webinar
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Specifically, this webinar will cover:
  • How ISO 14971:2019 applies to your company
  • Key changes from prior versions of the ISO 14971:2019 Standard 
  • Key timing for implementation of updates across different global requirements
  • Tips for creating the Risk Management file for new products
  • Tips for updating legacy Risk Management files to current standards
  • Effectively evaluating Risk Management files during design change
  • Effectively evaluating Risk Management files and incorporation of Post-Market Surveillance information
Who Should Attend?
  • Medical device executives
  • Quality Professionals and Quality Management
  • Regulatory Professionals 
  • R&D Engineers and Management
  • Product Engineers
  • Usability Engineers
  • Persons creating and/or updating Design Control processes
 Register Now  

Hosted by

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Presenter: Audrey Prosser

Quality Engineering, Exemplar Compliance
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Presenter: Rebecca Waterbury

Senior Advisor and Board Member, Exemplar Compliance
Taylor Brown
Moderator: Taylor Brown

Senior Medical Device Guru, Greenlight Guru

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About Exemplar Compliance

Exemplar Compliance is a global consulting firm specializing in Quality, Regulatory Compliance, Automated Quality Solutions, and Logistics. Experienced staff work with large and small companies to implement strategies for FDA remediation, product approval, product launch, quality system implementation, quality audits, and international logistics. The defining characteristic of their service is the implementation of practical, compliant, quality solutions. At Exemplar we believe that “Quality Matters,” and it is the only strategy for successful product approval and commercialization. We believe in educating our clients on every project and creating strong, knowledgeable teams. Exemplar Compliance works with companies in all phases of development and commercialization and across product types such as traditional pharmaceuticals, biologics, dietary supplements, medical devices, IVD, and combination products. 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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