Alese Devin, MS

I am a Regulatory Affairs Specialist with experience supporting the full lifecycle of software-as-a-medical device (SaMD), from regulatory strategy and development planning through design controls, submission, and design changes. I have guided SaMD products through FDA 510(k) clearance, EU CE marking, Health Canada licensing, and ANVISA notification. I have led front-room activities during MDSAP, ISO 13485, ISO/IEC 42001, and EU MDR notified body audits achieving compliance and successful audit outcomes. I hold an M.S. in Applied Biomedical Engineering from Johns Hopkins University and am passionate about helping bring safe, effective, and compliant healthcare technologies to patients.