I have worked with Donna Hartzfeld, Ph.D. at several companies and have found her to be professional, knowledgeable, and very proficient in medical device manufacturing practices. At Biomerics, she offered consulting services to prepare us for a combination medical device/pharmaceutical product. Her knowledge was useful in creating a gap analysis for quality system implementation. At MedPlast, She was invaluable in writing quality system documentation and improving our quality system. She was very thorough and professional in handling difficult situations and personalities. She also produced excellent quality work in a short period of time, which aided us in meeting our system deadlines. At Katecho she performed our ISO/FDA internal quality audits. She was flexible in handling our audits with very little notice and identified key areas to address our quality system deficiencies.

We recently worked together as part of a team to improve and reduce Lab Investigations for a client. Dr. Hartzfeld showed good problem solving skills and excellent technical competence in doing the Lab Investigations. Her communication skills in writing and verbally are very good.

Donna has been both adviser and regulatory consultant to Mission3. In both capacities she has been professional, knowledgeable, and thorough. Her ability to find the right answer and do work with incredible level of quality makes her an incredible asset to any team. She is personable and easy to work with

Dr. Donna Hartzfeld, and her company QIS, have been consummate professionals in every task. She has proven not only to be extremely knowledgeable technically, but also an expert in client relationship management. Dr. Hartzfeld is the first person I call whenever I have need of a qualified and dedicated scientist.