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!
Company Details
- Employees
- 6
- Founded
- -
- Address
- Morrisville, North Carolina 27560, Us
- Industry
- Medical Device
- Website
- qualitascompliancellc.com
- Keywords
- FDA 21 CFR Part 820 Compliance Services, ISO 14971 Risk Management Support, CE Mark Assistance, FDA Design Controls, Medical Device Certified Safety Testing Support, ISO 13485:2016 QMS Development, IEC 60601 Support Services, EU MDR 2017/745, ISO 13485:2016 Internal Audits and Supplier Audits, Medical Device File Review, Unique Device Identification (UDI) Assistance, QMS Training for ISO 13485:2016, Post Market Surveillance Support, Medical Device Consulting, FDA 483 Remediation, ASQ, CQA Lead Auditor Services, Medical Device Safety Testing Support, Medical Device Project Management, FDA 510k Submission Support, FDA 21 CFR Part 820 & ISO 13485:2016 Gap Analysis.
- HQ
- Morrisville, North Carolina
- Competitors
Qualitas Compliance, Llc Questions
Qualitas Compliance, Llc's website is qualitascompliancellc.com
Qualitas Compliance, Llc's LinkedIn profile is https://www.linkedin.com/company/qualitas-compliance-llc
Qualitas Compliance, Llc has
6 employees.
View email and phone details for 6
employees at Qualitas Compliance, Llc.
Qualitas Compliance, Llc's industry is
Medical Device
Qualitas Compliance, Llc's categories are Medical Device
Qualitas Compliance, Llc's founding year is 2013
