Most Serious Medical Device Recalls of 2015
Almost half as many devices were recalled this year compared to 2014.
Tag Archives: recalls
Communicating Device Issues to Patients? Align Your Message
Discussing device problems can have a serious affect on patients. Physicians, manufacturers, and FDA should clarify their message to maintain trust.
Supplier Responsibility in Medical Device Recalls
What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.
FDA Transparency at Heart of Device Risk and Recall Discussion
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
Device Manufacturers Still Grapple with Recall Risks and Next Steps
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
Four Ways Risk Analysis and Verification Testing Can Help Prevent Recalls
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
