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Medical Device Recalls: a Preventive Strategy-OnlineWebinar

Wednesday, Apr 26, 2017 at 10:00AM - 1:00PM

Online Event

  • Apr 2017

    26 Wed


  • Apr 2017

    26 Wed


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Medical Device Recalls: a Preventive Strategy-OnlineWebinar

Wednesday, Apr 26, 2017 at 10:00AM - 1:00PM


No tickets available

The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement - control throughout the product's life cycle.

The webinar will provide an overview and a foundation for further learning concerning preventing recalls during specification writing, risk assessment and risk management, preventing recalls during the early design and the detail design phases of development, and preventing recalls during validation, verification, and software design.

Objectives of the Presentation
At the completion of this training, participants will be able to:
  • Discuss the importance of developing a preventative strategy for preventing medical device recalls
  • Discuss how medical device recalls can be prevented during key aspects of the design, development, production, marketing, logistics, and utilization of a medical device
  • Explain how defects are prevented throughout the supply chain to prevent potential recalls
  • Discuss how the verification process is used to prevent recalls
  • Define management's role in preventing medical device recalls
  • Identify the innovative methods that are used to prevent medical device recalls
Why Should you Attend
In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2014 attributable to a variety of reasons. Whatever the reason, medical device recalls are expensive and most importantly carry significant risk to the health and safety of patients.

The increase indicates serious failures in the processes and controls designed to ensure reliability, safety and effectiveness of the recalled devices. As medical devices become more complex and software components become more critical to device functioning, the need for proactive risk prevention becomes more and more evident.

The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors - caused by faulty systems, processes and conditions; A failure of procedures and execution in other words, management failure.

Areas Covered
  • Preventing recalls during specification writing
  • Preventing recalls during early design
  • Preventing recalls during the detail design phase
  • Designing for Prognostics to protect patients
  • Preventing recalls during production validation
  • Preventing software design recalls
  • Preventing supply chain quality defects to avoid recalls
  • Preventing recalls using a verification process
  • Preventing recalls using the design validation process
  • Role of management in preventing recalls
  • Innovative methods useful in preventing recalls
Who will Benefit
  • CEOs
  • VPs
  • Clinical Affairs (Associates, Specialists, Managers, Directors or VPs)
  • Regulatory Affairs (Associates, Specialists, Managers, Directors or VPs)
  • Quality Professionals (Associates, Specialists, Managers, Directors or VPs)
  • R&D (Engineers, Scientists, Managers, Directors or VPs)
  • Complaint and risk management personnel
  • Consultants
  • Contractors/Subcontractors & Other Interested Parties.

For Registration

Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

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