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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
March 28, 2024

Key Expectations for ISO 14971 Compliance with Implementation of QMSR

Join this informative session as we explore ISO 14971 and the upcoming QMSR for medical device professionals.

Learn how to adapt your risk management processes to meet new regulations, including best practices to implement a risk-focused culture in your organization.

We'll cover essential updates, strategies for compliance, and practical steps for integrating risk management from development to post-market. Ideal for anyone working in medical devices.

Specifically, this webinar will cover:
  • QMSR expectations for Risk Management in the new regulation
  • Regulator expectations as described in the comments section of the QMSR
  • How to design your risk processes to meet regulator expectations
  • Common pitfalls in implementation of risk management and how to avoid them
  • Practical suggestions on how to implement risk-mindedness starting at the top

Watch the webinar
Key Expectations for ISO 14971 Compliance with Implementation of QMSR
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • R&D Engineers and Management
Register Now  

Hosted by

Etienne-Nichols-round
Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru
1-Mar-20-2024-05-31-30-5280-PM
Presenter:
Christie Johnson

Partner,
Prodct
2-Mar-20-2024-05-31-30-4976-PM
Presenter:
Ed Bills

Principal Consultant,
Edwin Bills Consulting

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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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About Prodct

Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors are deeply experienced medical device developers and manufacturers who provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments.

Prodct creates bespoke development, risk management, manufacturing, and quality strategies aligned with 21 CFR part 820, ISO 13485:2016, IEC 62304:2006, and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary.

Visit their website to learn more.

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