Cybersecurity: Protecting Interconnected Devices from Intrusion ‘Vital’, says FDA’s Ostroff
Industry shifts focus to proactive measures in addressing vulnerabilities and promoting cybersecurity.
Tag Archives: risk
FDA Encouraging Manufacturers to Proactively Prepare for Cybersecurity Vulnerabilities
The recently released draft guidance on cybersecurity stresses the importance of preparation versus reaction.
Solving Technology Hazards in Hospitals
ECRI’s top 10 hazards list drew attention to technology issues, and device manufacturers should be communicating with hospitals to address the problems.
Dirty Endoscopes Dethrone Alarms as Biggest Health Tech Hazard
ECRI’s annual list points the finger at poor cleaning of flexible endoscopes.
Weighing the Risks and Benefits of the Cloud
Device manufacturers are concerned about data availability and security, as well as risk to their brand.
Who’s Liable for 3-D Printed Medical Devices?
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
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.
Recent Pre-Market Activities at FDA
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.
Controlling Costs in Medical Device Development
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
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.
