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Medical Device Safety Monitoring and Reporting

Tue, 10/02/2012 - 11:15am

Key Speakers

Russ Davies
Vice President, Global Regulatory Affairs & Quality Systems, Smiths Medical

Marcela Rios Vessell
Vice President, Global Quality Systems, Manufacturing & Distribution, Integra LifeSciences

Kevin Escapule
Associate Director, Post-Market Surveillance , Zimmer Inc.

Kamel Chair, MD
Medical Advisor, Post-Market Surveillance, Stryker Neurovascular

Karen A. Weaver, JD, RPh
Vice-President & Associate General Counsel, Regulatory , CareFusion Corporation

Key Topics

  • Explore global requirements for medical device safety reporting with Merit Medical Systems
  • Gain a comprehensive understanding of FDA device guidances with Carefusion Corporation
  • Develop, maintain and implement MDR procedures for internal control systems with Cordis Corporation
  • Manage post-market product feedback for timely reporting and regulatory compliance with Philips Healthcare
  • Establish a device recall plan of action for a timely response with Arthrocare Corporation

Event Focus

Background
Given that the malfunction of a device can lead to fatality, the need to ensure these devices are safe and are monitored effectively is crucial. Any complaints on devices need to be monitored so that if there is a need to recall the device, it can be done effectively and quickly, without any further impact to patients.

Challenges
The ability to collect data from different sources and the need to understand and meet the different requirements for global regulations.

Why Should You Attend?
The Medical Device Safety Monitoring and Reporting Conference will be a two-day, industry focused event, specific to those within Regulatory Affairs, Quality Assurance, Medical Device Reporting and Clinical Affairs.

Attending this conference will enable you to:

  1. Address challenges with global reporting requirements
  2. Monitor the safety of post-market medical devices
  3. Maintain compliance when monitoring devices
  4. Establish strategies for device recalls and corrections
  5. Improve pre-market monitoring processes

This conference will bring together the leading medical device companies to discuss the current challenges faced when monitoring and reporting the safety of both pre-market and post-market medical devices. By attending, delegates will be able to leverage the safety and effectiveness of medical devices to mitigate risk when promoting products globally, as well as gain a better understanding of FDA and international reporting requirements.

This is not a trade show; our Medical Device Safety Conference is targeted at a focused group of senior level leaders to maintain an intimate atmosphere for the delegates and speakers. Since we are not a vendor driven conference, the higher level focus allows the delegates to network with their industry peers and speakers.

For more information, click here to view the event page.

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