About SheAlpha QA/RA Consulting

SheAlpha QA/RA Consulting was founded to help innovative medical device companies overcome regulatory barriers with clarity, confidence, and expert guidance. We bring more than a decade of experience supporting manufacturers across: U.S. FDA EU MDR Health Canada LATAM regulatory authorities ASEAN & APAC markets ISO 13485, ISO 14971, and international standards Our approach combines precision, industry expertise, and modern, remote-first workflows to deliver systems that work—not just for audits, but for everyday operations.

Our Values

Integrity: We protect your compliance and reputation.

Quality: Every document meets global regulatory standards.

Efficiency: We streamline processes without compromising safety.

Accessibility: Clear, no-jargon communication your whole team can use.