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

CAPA Assistance

CAPA Assistance for Medical DevicesQualitas can help you establish a CAPA system or can assist you in maintaining an already established system. Qualitas can assist with the following:

  • Writing Corrective and Preventative Actions.
  • Providing pointers on preventative actions that can be implemented within your specific organization.
  • Evaluating / determining root cause investigation and recommending short term and long term solutions.
  • Monitoring the CAPA system to determine if trends are existing.
  • Reviewing effectiveness of the CAPA system as a whole and determining the effectiveness of individual CAPAs.
  • Providing written feedback to executive management on the state of the CAPA system along with recommendations.




Helpful Links: FDA and Medical Device Industry

Name (required)

Email (required)

Phone

Company

Comments/Questions

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.

Learn More

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

Contact Us  |  Site Map