Resources
All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.
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
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
PMS/PMCF Readiness Assessment Checklist for EU MDR
Are you prepared to meet the more stringent PMS/PMCF requirements operative under MDR? Medical device manufacturers are required under the European
