Qualitas Compliance, LLC

Qualitas Compliance, LLC specializes in medical device compliance services including: ISO 13485, ISO 9001, ISO 14971 & FDA Part 820.

Qualitas Compliance, LLC is a women-owned business strategically located in Raleigh, NC. Qualitas focuses on successfully navigating the ever-changing quality and regulatory waters of the medical device industry. We exist to help our clients move quickly through the compliance aspects of establishing their business along with moving their products through the quality / regulatory paths in preparation for market entry. We understand what it takes to set up a company's quality system for compliance with ISO 13485, ISO 9001, ISO 14971, GMP, and FDA 21 CFR Part 820 along with compiling FDA ready regulatory submissions to move your product through the compliance channels.