Learn how to manage regulatory assessments for clinical trials for medical devices and medicinal products. Understand different scenarios and.
New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.
Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.
The new European changes in the medical device regulatory scope, and the particular characteristics of the Polish law.
The importance of Continuous Manufacturing (CM) and its different approaches. The new guidelines and trends of continuous manufacturing explained.
The European Commission proposed to extend the certification period for medical device suppliers by 4 years to avoid shortages. Are you compliant?
How can we best manage regulatory assessments? Here is three explanatory cases related to medicinal product clinical trials involving medical devices.
FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?
The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?
The US Breakthrough Device Designation Program can help your company speeding up your Medical Devices development, assessment and review.
