My background spans 25 years in the medical device industry, covering risk management, product development, regulatory compliance, and quality systems. Drawing on that experience, I lead Medestan Consulting, where we partner with medical device companies to provide expertise in compliance-focused areas such as regulatory filings, certification testing, human factors evaluation, and remediation support.

Our role is to make complex requirements clear and workable — ensuring alignment from early development through regulatory submission and post-market activities. With practical experience and a collaborative team approach, we help companies move forward with confidence that their products are safe, compliant, and aligned with regulatory expectations.