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 [...]
MDCG 2023-3 Rev. 2: Everything you need to know about the new vigilance rules
Important updates for manufacturers and importers: here’s what’s changing! [...]
Australia: New opportunities for medical device and IVD manufacturers
The Therapeutic Goods Administration (TGA) continues to modernize Australia's regulatory [...]
MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has released [...]
