Resources

All regulatory process charts are available to download from Regulatory Affairs Management Suite (RAMS).
Log into RAMS or create your free account to download this information.

LOG INTO RAMS

Get unlimited access to the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

EU MDR Readiness Checklist
EU MDR Readiness Assessment Checklist
How prepared is your company for compliance to the European Medical Devices Regulation (MDR)? Medical device CE Marking requirements will change
Read More
EU IVDR readiness checklist from Emergo by UL
EU IVDR Readiness Assessment Checklist
Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)? Under the IVDR, in vitro diagnostic (IVD) device
Read More