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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Quality System Development

We can provide Quality Management System support for:

Quality System Development

  • ISO 13485:2016 certification
  • FDA 21 CFR Part 820
  • EU MDR 2017/745
  • ISO 9001:2015

We can help with a turnkey, custom quality management system to meet regulatory and quality compliance or help you modify your current quality management system.

Qualitas can help!
We will conduct a gap analysis of your current system, isolate the weaknesses and help you determine cost-effective solutions to fit your company. We work with your team every step of the way and once your QMS is complete, Qualitas can provide training on the new process areas.

Once the Quality Management System is established, we can assist with walking your team through ISO 13485 Certification.

From initial contact with the registrar to providing representation during the Stage 1 and Stage 2 certification assessment, Qualitas can help you with every step along the way!




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.

– – Contact Us – –

Qualitas Compliance LLC
621 Hutton Street
Suite 104
Raleigh, NC 27606
919-964-0939

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