FREE ON-DEMAND WEBINAR
October 24, 2024

Integrating Risk Management & CAPA: How to Supercharge Your Medical Device Quality

Did you know that over 60% of medical device quality issues stem from ineffective CAPA processes, and nearly half of all FDA warning letters cite deficiencies in risk management?

CAPA and risk management are not just regulatory requirements but essential components of ensuring product safety and compliance in the medical device industry. 

Despite their importance, many MedTech companies miss the opportunity to leverage them together for maximum impact.

So, how can you effectively link these critical processes to enhance product safety, streamline quality management, and ensure regulatory compliance?

Join us for an insightful webinar led by Kyle Rose, President of Rook Quality Systems, as he explores the critical connection between risk management and CAPA, and how to integrate these functions to proactively mitigate risks, prevent future nonconformities, and elevate the overall effectiveness of your QMS.

Specifically, this webinar will cover:
  • The connection between risk management and CAPA in medical device quality
  • How to leverage CAPA data to enhance your risk management process
  • Practical steps for integrating risk management and CAPA within your QMS
  • Best practices for identifying, mitigating, and tracking risks through CAPA
  • Case studies demonstrating successful risk management and CAPA integration

Watch the webinar

Integrating Risk Management & CAPA How to Supercharge Your Medical Device Quality-1
Who should attend?
  • Quality Professionals and Management
  • Regulatory Affairs Professionals & Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • Risk Managers
Register Now  

Presented by

Etienne-Nichols-round
Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru

Greenlight Guru logo

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.

Rook-Logo-08-21-01-1

Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems.

Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook's team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs).

Visit their website to learn more.

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