U.S. FDA Medical Device Predicate Selection for 510(k) Submissions
Learn more about the strategies for tackling challenges and boosting submission success for FDA 510(k) predicate selection.
Overview of the IVD regulatory landscape in Brazil
Learn more about the IVD regulatory landscape in Brazil.
Public Database for Clinical Investigation Report and Summaries
Some manufacturers have already completed clinical investigations and are required by regulations to store the report. The European Commission (EC) has created a dedicated public CIRCABC directory called “MDR Clinical Investigation reports and their summaries."
EU MDR Conformity Assessment Options for Medical Devices
Learn more about the EU MDR conformity assessment options for your medical devices.
Gradual roll-out of EUDAMED
When to expect the first modules of EUDAMED to become mandatory for medical devices and IVDs in the EU.
Medical Device Regulations in China
Are you seeking new opportunities for your healthcare devices? This whitepaper outlines the latest requirements for successful market entry in China.
Optimization for Global Vigilance Reporting
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on optimization for global vigilance reporting.
Global Unique Device Identification for Medical Devices
This whitepaper outlines global UDI regulations, the FDA’s role in adoption, and resources for medical device companies navigating regulatory compliance.
What the MDCG regulatory guidance document regarding ethylene oxide covers
Learn what the latest MDCG guidance document on ethylene oxide covers.
EU Update: New MDCG Guidance Document 10a
Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents.