Medical Device Recalls - a Prevention Strategy

Why Should You Attend:

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.

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.

Learning Objectives:

At the completion of this webinar participants will be able to:

• Explain the structure of an effective medical device recall prevention strategy
• Explain how recalls can be prevented at each stage of medical device design and development

Areas Covered in the Webinar:

• 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:

• Engineers,
• Managers,
• Supervisors,
• Scientists,
• Technicians, and other personnel involved in product development,
• Manufacturing, quality assurance,
• Regulatory affairs that require a basic understanding of the regulatory submissions process.

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

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