Preventing Medical Device Recalls – A Prevention Strategy
Prevent Device Recall by Controlling Safety Risk Throughout the Product’s Life Cycle!
Instructor :
Charles H. Paul
Webinar ID:
3398
Date: DEC 18, 2024 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins
What you will learn
- Preventing Recalls during Specification Writing, Early Design, the detail Design Phase
- Preventing Recalls during Production Validation, Verification Process
- Preventing Software Design Recalls
- Preventing Recalls during Specification Writing, Early Design, the detail Design Phase
- Preventing Recalls during Production Validation, Verification Process
- Preventing Software Design Recalls
- Preventing Supply Chain Quality Defects to Avoid Recalls
- Preventing Recalls using the Design Validation Process
- Role of Management & Innovative Methods to avoid Expensive Recalls
Course Description
In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2021 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.
Join Mr. Paul to learn the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating costly device recalls. Join Now!
In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2021 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.
Join Mr. Paul to learn the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating costly device recalls. Join Now!
Why you should 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
- Preventing recalls during validation, verification, and software design
This webinar will help medical device designers and manufacturers exceed their customers’ expectations for quality and safety. Join to learn more…
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
- Preventing recalls during validation, verification, and software design
This webinar will help medical device designers and manufacturers exceed their customers’ expectations for quality and safety. Join to learn more…
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
- 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 is this course for
Medical Device Designers and Manufacturers. Anyone involved in the manufacturer of medical devices that has had some exposure to the subject area and regulated environments..
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates..
Medical Device Designers and Manufacturers. Anyone involved in the manufacturer of medical devices that has had some exposure to the subject area and regulated environments..
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates
- Supervisors
- Managers
- Directors
- Vice Presidents
Instructor Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
