Anne Holland

CEO And Founder at QA Consulting, Inc.

Anne Holland is the Founder and CEO of QA Consulting, Inc., with over 30 years of expertise in Quality and Engineering leadership within the medical device industry. Prior experience includes serving as Quality Manager at CarboMedics, where team management encompassed regulatory compliance and audit observations, and as Design Assurance/Project Manager at Datex-Ohmeda, focused on design verification for Oximeters. Additional roles include Project Engineer at Cobe Laboratories, where responsibilities involved quality audits and FDA assistance. Anne Holland holds an MBA in Business from the University of Colorado Denver and a B.S. in Biomedical Engineering from Vanderbilt University.

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Austin, United States

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QA Consulting, Inc.

QA Consulting, Inc. is your trusted thought partner for innovative medical device consulting and outsourced quality assurance services tailored to meet your objectives throughout the product lifecycle. We offer custom solutions in the areas of: - Quality Systems - Regulatory Affairs - Microbiology Analysis From startups to multinational corporations, discerning medical device manufacturers of all sizes rely on our real-world knowledge, expert documentation, and mastery of industry protocols and procedures to navigate today’s constantly evolving regulatory environment. We are quality connoisseurs that help you jump through compliance hurdles with ease. Our areas of expertise include: - Quality system development - Audits (internal, supplier, notified body) - U.S. FDA strategy - Post-market compliance - Microbiology (biocompatibility, bioburden, endotoxin, sterility, and more) - Helping startups bring their first product to market Lean into quality with medical device systems everyone can trust.


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