Qualitas Compliance LLC

  • About Us
  • Services
    • Quality System Development
    • Contract Auditors
    • CAPA Assistance
    • Certified Safety Testing
    • Gap Analysis
    • Risk Management
    • Onsite Training
    • Regulatory Support
    • Project Management
  • Standards
  • Blog
  • Careers
  • Contact

Medical Device Consulting to Streamline Compliance and overcome regulatory challenges.

Quality System Development

We can provide Quality Management System support for: ISO 13485:2016 certification FDA 21 CFR Part 820 EU MDR 2017/745 ISO 9001:2015 We … More...

Gap Analysis

Whether 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 … More...

Risk Management

Risk management in accordance with ISO 14971 is critical for any medical device.  It is important for the company to have a … More...

Our Mission:

Providing experience, exceptional insight and understanding to start-up and mid-sized companies seeking to achieve the necessary quality and regulatory compliance in order to design, manufacture or sell an FDA-approved product.

CAPA Assistance

Qualitas can help you establish a CAPA system or can assist you in maintaining an already established system. Qualitas can assist with … More...

Contract Auditors

Qualitas can help with your compliance auditing needs. We have ASQ, Certified Quality Lead Auditors that can conduct audits for compliance … More...

Safety Testing

Medical devices are required to show they perform safely and effectively. Depending on the type and classification of device, certified … More...

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
919-964-0939

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