One town in Pennsylvania is preparing for the Papal visit by equipping its various sites with defibrillators.
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
Discussing device problems can have a serious affect on patients. Physicians, manufacturers, and FDA should clarify their message to maintain trust.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
The bill has received bipartisan support for removing barriers and accelerating innovation in medical devices, drugs and biologics.
Our content and conferences are stronger than ever, and our new name, MedTech Intelligence, reflects a continued commitment to the medical device industry.
Finding ways to better manage inventory, provide security and product integrity, and maintain continuous improvement are among the goals of logistics professionals.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.
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.