Tips from industry peers who are going through the process.
A guide to a risk-based CAPA program for device manufacturers.
Industry shifts focus to proactive measures in addressing vulnerabilities and promoting cybersecurity.
The recently released draft guidance on cybersecurity stresses the importance of preparation versus reaction.
ECRI’s top 10 hazards list drew attention to technology issues, and device manufacturers should be communicating with hospitals to address the problems.
ECRI’s annual list points the finger at poor cleaning of flexible endoscopes.
Device manufacturers are concerned about data availability and security, as well as risk to their brand.
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
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.