“In the rapidly evolving landscape of regulatory and quality compliance in healthcare, there’s a difference between active and passive documentation. Passive documentation might comply with regulations and get a company through an audit, but active documentation addresses the reasoning behind the regulations, fits like a puzzle piece into a product’s development and life cycle, and always…. always puts the patient first.”
Robert Zott brings more than 20 years of experience in regulatory affairs and quality compliance to Nerac. As Program Director for Technology Development at Covidien Surgical Devices, he was responsible for the strategic development and submissions authorship for soft tissue implants and advanced laparoscopic instruments. At Underwriters Laboratories, he contributed to the development and accreditation of the UL ISO 9000 Registration Program. As a BSI-certified lead auditor, he conducted pre-assessment audits and consulted on topics ranging from CE-marking to biomedical investment, and he has lectured extensively on regulatory and quality compliance to organizations ranging from local ASQ chapters to the U.S. Department of Commerce.
Mr. Zott currently serves as Director of Advisory Services Development at Nerac, Inc., collaborating with medical device clients on Clinical Evaluation Reports and 510(k)s. He also provides expert guidance on pathways to market approval.
- Regulatory Affairs
- Quality Compliance
- Medical Devices
- B.S., Physics, Albany State University