Medical Device Recalls – A Complete Prevention Strategy
- Speaker:Charles H. Paul
- Product Code:GRC-90350
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In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2017 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.
- 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
- Medical Device Industry
- Personnel involved in Product Development
- Quality Assurance
- Regulatory Affairs that require a basic understanding of the regulatory submissions process.