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Implementation Timelines for EU MDR and IVDR
On May 5th, 2017 the European Union Medical Device Regulation (EU MDR) was officially published and was entered into force on May 26th, 2017. The new regulation, which is binding in its entirety, will have a direct...
The Cyber-Security of Medical Device Companies
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities....
New Medical Device Regulation in Russia
The Ministry of Health of the Russian Federation is the country’s regulatory body for healthcare concerns. They recently released a change in regulation for medical devices. All Medical Device Registration...
New CFDA Regulations on Device Clinical Trials
The China Food and Drug Administration (CFDA) has been changing how medical devices are regulated by expanding and updating their laws. They have released multiple draft documents which elaborate on the caliber of...
Reminder: UDI Implementation Due Date Approaching
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs....