Robert Mueller has 8 years of experience working in the medical device industry. He has developed a unique perspective on testing from working for both a contract research organization and a medical device manufacturer. During his time with the medical device manufacturer, he planned and managed the execution of biological testing, chemical characterization, and wrote toxicological risk assessments for both MDR and 510(k) submissions. He is an ISO 10993-18 subject matter expert and as such he has designed custom studies for a broad range of medical devices to meet the biocompatibility requirements outlined in ISO 10993. He has provided all levels of regulatory support to a wide range of medical device companies. His expertise includes developing and qualifying analytical methods as well as conducting analytical data reviews. He has also authored regulatory body submissions and deficiency responses. Robert is currently a toxicologist at Nelson Labs.
