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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 CAPA Management Audit Management Product Development

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

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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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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FREE ON-DEMAND WEBINAR

How to Integrate Risk Management throughout the Lifecycle of a Medical Device in the Coming Decade

By its very nature and application, there is an element of risk in the use of any medical device.

Understanding, balancing, and quantifying that risk enables a manufacturer to bring a product to market that provides significant benefit to patients and health care providers while minimizing the risks associated with the product.

With updated guidelines to risk management, outlined in ISO 14971:2019, the industry is still waking up to the benefits of integrating design, risk, and postmarket quality activities over the course of the device lifecycle.

This webcast will review the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, production and postproduction monitoring) as a product moves through the product lifecycle (concept, development, launch, postmarket, obsolescence).

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Specifically, this webinar will cover:
  • How risk management is an integral part of all phases of the product lifecycle
  • Common challenges and data-driven insights on key markers for risk management
  • How to leverage proven strategies, tactics, and technologies to control and monitor risk management activities
  • How to achieve closed-loop traceability via a risk-based approach to postmarket surveillance to monitor and address product issues and ensure patient and healthcare provider safety.
  • Ongoing risk management to balance patient/health care provider risks versus benefits of the medical device.
  • Q&A session
Who Should Attend?
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Clinical Affairs Professionals and Management 
  • Product Development & R&D Engineers and Management
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Hosted by

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Moderator/Presenter: Jon Speer

Founder, Greenlight Guru
loopMark

About Greenlight Guru

Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices.

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