Qualitas Compliance, LLC

medical devices

About

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!

Technologies

Gmail Google Apps Google Font API WordPress.org Google Tag Manager Mobile Friendly IoT Domo Sisense KNIME

Keywords

medical device file review regulatory writing support services iec 60601 support services iso 134852016 qms development asq iso 14971 risk management support medical device safety testing support iso 13485 9001 qms development iso 134852016 internal audits & supplier audits fda 510k submission support fda 21 cfr part 820 iso 134852016 gap analysis medical device consulting fda 21 cfr part 820 compliance services medical device certified safety testing support iso 13485 amp 9001 qms development fda 483 remediation ce mark assistance unique device identification assistance medical device project management capa assistance regulatory writing amp support services qms training for iso 134852016 fda design controls post market surveillance support cqa lead auditor services medical compliance training gap analysis services eu mdr 2017745 contract auditing services iso 13485

Location

11010 Lake Grove Blvd, Morrisville, North Carolina, United States, 27560

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