App Profile: Regulatory Globe MDR / IVDR

William Bauer

Rating: 5/5

To gain knowledge in order to assess & apply the MDSAP Audit Model, I reviewed the country-specific requirements as organized in my downloaded copy of Regulatory Globe’sMDSAP Checklist (Excel file/tool that I purchased). In turn, I leveraged its contents for practical use in my role as a Certified MedDev Quality System Lead Auditor, by building a repository-of-links to country-specific requirements, and, in parallel, annotating the Checklist to add self-written guidance and reduce redundancies. The MDSAP tool saved countless hours of time. In kind, I also appreciate the convenience of this Regulatory Globe MDR / IVDR App (downloaded on my iPhone) and its accompanying Regulatory updates for EU Regulatory Compliance purposes. I may buy the Excel-version of RG’s MDR Gap-Tool for benefits similar to my MDSAP Checklist, but this free App is a welcome resource.