Qualitas Compliance, LLC is a women-owned business strategically located in Raleigh, NC minutes from the Raleigh Durham Airport and the Research Triangle Park. 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 13485:2016, 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.

Whether you need assistance in writing a single Standard Operating Procedure (SOP), setting up a complete quality management system from scratch, conducting risk management activities, generating a gap analysis, assisting with the Corrective & Preventative process, training, or conducting audits, our knowledgeable and talented team is here to help you achieve compliance!

Qualitas Compliance, LLC

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