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Medical Device Regulatory Expert

Specialties & Experience of this Expert Witness

Additional Information

Anne Holland is a medical device regulatory compliance, quality systems, and design controls testifying expert with more than 35 years of experience in the medical device industry. Her expertise includes FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, EU MDR, design controls, risk management, CAPA, complaint handling, adverse event investigations, supplier quality, auditing, and post-market surveillance. She has held executive leadership positions and founded QA Consulting, Inc., which has provided quality and regulatory consulting services to hundreds of medical device manufacturers. Ms. Holland has substantial experience as a testifying expert in medical device product liability litigation, including U.S. multidistrict litigation and Australian Federal Court proceedings involving implantable medical devices. Her expert witness experience includes two trial testimonies, eight depositions, thirteen expert reports, and multiple forensic consulting engagements involving pelvic mesh, hernia mesh, orthopedic implants, quality management systems, design controls, risk management, complaints/adverse events, audits, and regulatory compliance matters. Professional certifications include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Registered Quality Assurance Professional (RQAP-GLP), Exemplar Global Lead Auditor, EU MDR Auditor, MDSAP Auditor, and IVDR certification.