Qualitas Compliance LLC

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    • Quality System Development
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Gap Analysis

Regulatory Compliance Services by Qualitas ComplianceWhether you need a gap analysis performed on your internal SOP’s for compliance to ISO 13485 or ISO 9001, Gap analysis to meet FDA 21 CFR Part 820, or to the international electronic commission standards of IEC60601-1, IEC60601-1-2, IEC60601-1-11 or ISO 14971 we can assist you. Qualitas conducts the gap analysis to determine where your deficiencies lie and can also conduct a gap analysis for your facility and overall QMS readiness for outside audits. We can conduct an onsite gap analysis or can conduct an analysis remotely through electronic file transfer. Contact us today to set up your gap analysis to ensure you can achieve compliance.




Helpful Links: FDA and Medical Device Industry

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About Us

Qualitas Compliance, LLC is a women owned business focused on successfully navigating the ever-changing quality and regulatory waters of the medical device industry.

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Medical Device Compliance – Charlotte

Services

Qualitas specializes in providing quality system management, compliance assistance and gap analysis in the medical device industry.  We provide services to companies throughout the USA and Canada, more recently in Raleigh-Durham-Chapel Hill, Charlotte, Atlanta, Tampa, Boston and Pittsburgh.  We are ready to help your team.

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Qualitas Compliance LLC
919-964-0939

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