Tom Middleton is a solutions architect for Sparta Systems Inc. Formerly an ASQ/RAB-accredited lead auditor for Underwriter’s Laboratories and Bausch + Lomb’s surgical division, Middleton has conducted nearly 1,000 registration, surveillance, internal, and supplier audits. Currently, he is an ASQ-certified biomedical auditor. Middleton’s experience includes auditing of compliance to good manufacturing practices, international standards, and regulations for automotive, life science, medical device, and the consumer product vertical sectors, including: ISO 9001, ISO 13485, ISO 14000, FDA 21 CFR 820, Japanese Pharmaceutical Affairs Law (JPAL), Canadian Medical Devices Conformity Assessment System (CMDCAS), EU Medical Device Directive (MDD), and the Brazilian ANVISA standards.
Here's what you need to know about the new clarifications on medical device reporting, which impacts all manufacturers of legally marketed medical devices in the U.S. (including foreign manufacturers who export devices to the U.S.).