Todd A. Rhodes is a Senior Director of Compliance at AlvaMed. Todd has over 20 years of experience in the medical device industry and has held leadership roles at various companies, including Quality Systems Manager and Director of Quality for for Class II and Class III products in the US, and Class IIb in in the EU. He is an expert in managing all elements of a company’s Quality Management and Risk Management systems, with a unique ability to tailor procedures to meet specific company needs. He is also a Certified ISO 13485 Lead Auditor with extensive experience conducting and hosting regulatory and supplier audits. Todd’s accomplishments include the following:
Quality Systems
- Implemented and managed Quality Management Systems to comply with FDA QSR, ISO 13485, and EU Medical Device Regulations.
- Led improvements in key quality processes such as Complaints Management, Supplier Management, Design Control, CAPA, and Document Management.
- Completed multiple successful usability studies, facilitated formative and summative studies, and supported the remediation of usability processes for an infusion pump manufacturer to meet FDA 483 requirements.
- Developed new procedures to improve the Clinical Evaluation Report (CER) development process for a medical imaging manufacturer.
Risk Management & Regulatory Support
- Developed comprehensive risk management files and documentation for various devices, including infusion pumps and surgical products, to meet ISO 14971 requirements.
- Supported product development by conducting risk management and usability assessments and reviewing documentation for regulatory submissions.
- Authored over 10 clinical evaluation reports (CERs) for Technical Files to meet Medical Device Directive (MDD) requirements.
- Provided support for regulatory submissions to the FDA and international bodies, including 510(k), De Novo, and IEC 60601-1 submissions.
Todd holds a Master of Business Administration from The University of Michigan and a Bachelor of Science in Operations Management from The Pennsylvania State University. He is a Certified ISO 13485 Lead Auditor and has held other certifications, including ASQ Certified Biomedical Auditor and ASQ Six Sigma Black Belt.
