Qualitas Compliance, LLC

Qualitas Compliance, LLC is a women-owned consulting firm specializing in medical device regulatory compliance and quality management systems. The company focuses on helping start-up and mid-sized medical device companies navigate FDA requirements and international standards to design, manufacture, and sell approved products.

The firm provides services across quality system development, gap analysis, risk management, CAPA assistance, and contract auditing. Their team includes ASQ Certified Quality Lead Auditors who conduct compliance audits for ISO 13485:2016, FDA 21 CFR Part 820, EU MDR 2017/745, and ISO 9001:2015. They also offer certified safety testing, onsite training, regulatory documentation support, and project management services specific to the medical device industry.

Qualitas serves clients throughout the United States and Canada, with recent activity in Raleigh-Durham-Chapel Hill, Charlotte, Atlanta, Tampa, Boston, and Pittsburgh regions.

Choose Qualitas Compliance when your medical device company needs specialized regulatory expertise without the overhead of full-time hires. Their focus on start-ups and mid-sized manufacturers means they understand resource constraints and can provide targeted support for certification milestones.

Expect hands-on consulting from certified quality auditors who understand both FDA and international standards. Their contract auditor model works well for companies preparing for regulatory submissions or maintaining compliance between internal audit cycles.

Qualitas Compliance operates exclusively within the medical device regulatory ecosystem. Their services address the specific compliance requirements medical device manufacturers face from the FDA (21 CFR Part 820), ISO standards (13485:2016 for quality management and 14971 for risk management), and European Union regulations (MDR 2017/745).

The firm's healthcare expertise centers on quality system development, safety testing certification, and regulatory documentation that medical device companies must maintain throughout the product lifecycle from design through post-market surveillance.

Medical device start-ups or mid-sized manufacturers preparing for initial FDA 510(k) submissions, ISO 13485 certification, or EU MDR compliance. Companies with established products needing temporary quality system support, gap analysis before regulatory audits, or contract auditors to supplement internal teams.