- 512-328-9404
- info@qaconsultinginc.com
We provide expert quality, regulatory and microbiology consulting to help established medical device, IVD companies, and government agencies achieve compliance, reduce risk, and move confidently through FDA and global regulatory requirements.
Over 400 Years of Combined Consulting Experience. 15 Consultants supporting medical device, IVD, and public health organizations.
Over 250 Audits Conducted Across Regulated Environments. Supplier, internal, and multi-facility audits supporting FDA and ISO compliance.
Over 150 Quality Systems Implemented or Remediated. ISO-aligned quality systems built to support growth, audits, and regulatory approvals.
QA Consulting provides specialized consulting services for medical device manufacturers, in vitro diagnostic companies, and government agencies navigating complex regulatory and quality requirements.
With over 25 years of industry experience, we support established and mid-sized companies with FDA submissions, ISO-compliant quality systems, microbiology and sterilization strategy, and global regulatory readiness. Our role is to reduce compliance risk, accelerate regulatory clearances, and strengthen long-term regulatory success.
We deliver targeted consulting services designed to support product approval, compliance, and operational excellence across regulated medical device environments.
Focus Areas
Focus Areas
Focus Areas
Our consulting services are designed for organizations operating in regulated, high-risk environments where compliance and documentation are critical.
We work with:
Our experience spans commercial product approvals, supplier audits, and large-scale government contracts, including public health initiatives.
Whether you are preparing for an FDA submission, strengthening or remediating your quality management system, or addressing microbiology, sterilization, or cleanroom compliance challenges, our consultants are ready to support your next phase of growth with clarity and confidence.
Our Consultants support medical device, IVD, and public health organizations across FDA approvals, ISO compliance, and global regulatory frameworks—delivering practical, execution-focused guidance grounded in real-world experience.
We specialize in supporting medical device organizations with products on the market or approaching commercialization. Our consulting model is intentionally designed for companies navigating:
Our long-term client partnerships are built on accuracy, regulatory confidence, and consistent results across regulated industries.
At QA Consulting, Inc., we take pride in building long-term partnerships with medical device companies ranging from innovative startups to established manufacturers. Here’s what our clients have to say about working with our team.
Our consulting services are grounded in recognized international standards and regulatory frameworks, supported by organizational and individual consultant certifications, including:
Navigating the New Quality Management System Regulation: Insights from Our Latest White Paper We are excited to announce the release of our
Author: Anne Holland, CEO and Founder Once your quality system is updated for QMSR, the next critical step is ensuring it’s not
We’d like to welcome QA Consulting’s new Senior Quality and Microbiology Consultant, Adrienne Schroll! We’re thrilled to introduce Adrienne Schroll, a
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