Medical Device Software Remediation & Compliance Fixes | Orthogonal
222 W Merchandise Mart Plaza #228, Chicago, IL 60654
(312) 374-6490
https://maps.app.goo.gl/KqJjFDewKpFXk63P7
https://orthogonal.io/remediation/
Get back into compliance and stay there with Orthogonal’s medical device software remediation services. If your SaMD or connected device software has fallen out of compliance—risking delays, failed inspections, or FDA 483 warning letters—we provide a clear path forward. Our process starts with a gap analysis against CFR 820, EU MDR, ISO 13485, IEC 62304, and ISO 14971. We then implement corrective and preventative actions, establishing efficient design controls specific to SaMD. Unlike general consultants, Orthogonal specializes in software, helping you resolve underlying issues while your developers stay focused. Whether you need a prioritized roadmap or hands-on fix, we deliver a minimally invasive compliance overhaul. Contact us to remediate quickly and build lasting quality processes.