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.

Donna is a subject matter expert in FDA regulatory compliance. She has performed in various consulting capacities for many clients and has a reputation for getting the job done thoroughly and with a high client satisfaction. It has been a pleasure to work with her and I highly recommend Donna for her knowledge and professionalism.

Certainly when you retain a regulatory affairs consultant, you look for subject matter competence.  Donna goes well beyond that, offering company-specific advice, understanding time sensitivity, and providing the care needed in a start-up environment.  I strongly recommend her.

Donna has provided timely and effective quality management consulting to my firm over the years. She is both very knowledgeable and personable, making interacting with her productive and enjoyable.