Ironwood MedTech Software

I am a seasoned engineering leader with over 25 years of experience delivering innovative medical devices, advanced systems, and embedded technologies. My career spans leadership roles in global organizations where I’ve driven transformational R&D initiatives, enhanced operational efficiency, and developed groundbreaking solutions that balance cutting-edge innovation with rigorous regulatory compliance. I have established processes and built teams to deliver highly reliable and secured medical devices, and can do the same for yours. Services Provided: ✦ Medical Device Security • Cybersecurity Risk Management Plans • Threat Modeling & Vulnerability Assessments • Cybersecurity Requirements and Design • Cybersecurity Questionnaire Responses • Product Security Incident Response Plans • DHA RMF Management • Conformance to ANSI/AAMI SW 96, IEC 81001-5-1, FDA Cybersecurity Guidances ✦ Software Development Life Cycle • Planning & Project Management • Use Cases & Requirements Analysis • Software and System Verification & Validation • Change Management • Process Improvement • Compliance to IEC 62304, IEC 82304-1, and FDA Design Controls