Conditional CE certificates: A new pathway for faster market access?
Over the past few years, the medical device industry has [...]
Data integrity in medical device testing – A critical FDA concern
Why data integrity in medical device testing is more important [...]
AI and medical devices: The UK defines a new regulatory path
Artificial Intelligence is transforming the healthcare industry, providing increasingly sophisticated [...]
New recall procedures in Australia: what changes with PRAC?
March 5, 2025, marked a significant step forward in [...]
UK IVD Registration: Key Updates for Manufacturers with Expiring CE Certificates
New MHRA guidance on in vitro diagnostic (IVD) device registration [...]
Electronic IFU Medical Device: EU MDR Digital Proposal
Is the era of paper-based instructions coming to an end? [...]
CMC Medical Devices at CMEF Shanghai 2025: Meet Us at Hall 8.1 Booth E10!
We’re back at CMEF Shanghai this year! From April 8 [...]
The European Union and MDSAP: A New Opportunity for Medical Device Certification
The Medical Device Single Audit Program (MDSAP) is one [...]
New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
The European certification system continues to expand with the [...]
New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant [...]
