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!
View Top Employees from Qualitas Compliance, LLCWebsite | http://www.qualitascompliancellc.com |
Revenue | $391000 |
Employees | 2 (2 on RocketReach) |
Founded | 2013 |
Phone | (919) 964-0939 |
Technologies |
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Industry | Medical Devices, Management Consulting, ISO 13485 & 9001 QMS Development, Business Services, Contract Auditing Services, Regulatory Writing & Support Services, FDA 21 CFR Part 820 Compliance Services, Medical Compliance Training, ISO 14971 Risk Management Support, CE Mark Assistance, Gap Analysis Services, CAPA Assistance |
SIC | SIC Code 87 Companies, SIC Code 874 Companies |
NAICS | NAICS Code 54 Companies, NAICS Code 541 Companies, NAICS Code 5416 Companies, NAICS Code 54161 Companies, NAICS Code 541611 Companies |
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The Qualitas Compliance, LLC annual revenue was $391000 in 2024.
Sarah Evans is the President of Qualitas Compliance, LLC.
2 people are employed at Qualitas Compliance, LLC.
Qualitas Compliance, LLC is based in Morrisville, North Carolina.
The NAICS codes for Qualitas Compliance, LLC are [54, 541, 5416, 54161, 541611].
The SIC codes for Qualitas Compliance, LLC are [87, 874].