Anne Holland

Principal, Anne Holland Consulting

Anne Holland combines more than 25 years of biomedical engineering with business acumen as founder and CEO of QA Consulting, Inc. She is an expert in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance for Class I, II, and III medical devices. Anne’s expertise has been sought by medical device manufacturers, from startups to Fortune 500, to develop and implement compliant solutions that meet their quality and regulatory needs. 
 

Anne has been called as an expert witness in numerous legal cases to conduct forensic regulatory and quality assurance investigations when a medical device may have contributed to death or injury, including expert deposition and trial testimony. She has been an expert witness in areas such as FDA compliance, quality assurance systems, hernia and pelvic mesh, the manufacture of hips, post-market compliance, risk management and design control. 
 

She has conducted over 100 supply chain and internal audits. Clients rely on her thorough knowledge of good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory remediation. She facilitates and responds to FDA and ISO 13485 Notified Body audits for manufacturers.