Medical Systems Consult

Medical Systems Consult is a boutique consulting firm with expertise in all aspects of medical device development, including regulatory compliance, software development, systems engineering, and risk management. We can help clients navigate the process from initial strategy to market release, and we offer technical services to augment your R&D teams and prepare technical documentation, regulatory submissions, and post market remediation work. We can also conduct internal audits, assist with responding to FDA Warning Letters and Form 483, conduct gap analyses and establish remediation plans, and update your Quality Management System to align with regulations and state of the art standards.