The expanding international market poses a variety of challenges for medtech companies entering new global territories.
You can never do enough due diligence.
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.
Device companies need to think about how their product interacts with systems and users.
How to prepare for a successful transition.
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The recently released draft guidance on cybersecurity stresses the importance of preparation versus reaction.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.