Qualitas Compliance LLC

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    • Quality System Development
    • Contract Auditors
    • CAPA Assistance
    • Certified Safety Testing
    • Gap Analysis
    • Risk Management
    • Onsite Training
    • Regulatory Support
    • Project Management
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Risk Management

Risk Management Consulting by Qualitas ComplianceRisk management in accordance with ISO 14971 is critical for any medical device.  It is important for the company to have a comprehensive risk management plan in place and to ensure that risk mitigation activities take place early within the medical device design process.  Qualitas can provide risk management activities and plans that meet the requirements of ISO 14971.  FDA requires an independent reviewer to participate with the risk management reviews and Qualitas can act as this. We can help you through every step of the risk management process and will work side-by-side with you to streamline this process and help you 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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