The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Updated...
In order to commercialize in vitro diagnostic (IVD) devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for IVDs, which will soon change under the new In Vitro Diagnostic...
We are proud to announce that Titan Solutions has received ISO 13485:2016 certification for the assembly of medical testing kits for the medical device and in vitro diagnostics industry View our ISO 1345 cert here. “We are delighted and proud to...
The IVD sector is growing rapidly due to rising healthcare costs and consumer demand which has created a need for advanced tools that are fast, accurate, informative, affordable, and less invasive for clinical decision making. This shift within the healthcare industry...
