RAMS 2.5 launches, expanding automated RA/QA capabilities for medical device and IVD companies

EMERGO by UL has rolled out powerful new enhancements to its Regulatory Affairs Management Suite (RAMS) digital platform for more efficient, cost-effective medical device and IVD regulatory affairs and quality assurance (RA/QA) operations.

RAMS 2.5 features new Smart Builder tools for streamlined generation and formating of EU MDR Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP); a Product Classification Tool for new as well as existing medical device registrations; and new resources including regulatory process charts, country reference documents and FAQs for eight new markets in Europe and Asia.

The RAMS platform is  now used by 10,000 medical device and IVD companies to automate RA/QA activities and ensure regulatory compliance in their active markets. Manufacturers may learn more by reading our RAMS 2.5 press release.