Medical Device Safety and Quality
This page provides blogs, short videos and recordings focused on the trends for medical safety and quality, including insights into risk management, product design, market research, post-market surveillance and regulatory intelligence.
Recent Blogs
ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know
As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.
How Does Software as a Medical Device Relate to Unique Device Identification?
Determining Software as a Medical Device is essential for regulatory compliance. This involves classifying software as a Device Component, Accessory, or Standalone Device, and understanding FDA’s UDI requirements and the implications of software changes on device identification.
EU’s Requirement for Implant Cards Provides Key Information for Patients
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices,...