Mary R Hole

Mary R Hole approaches inspections with a meticulous and detailed focus on documentation, accuracy, and adherence to regulatory requirements. She prioritizes the thoroughness and precision of reporting, particularly in the context of medical device corrections, design changes, and audit actions. Additionally, she places a high emphasis on contamination control, especially related to surgical instruments and intrasurgical cleaning procedures.

Mary R Hole is a detail-oriented FDA auditor who focuses on change control, complaint management, audit management, and contamination control. She is particularly interested in ensuring the accurate reporting of corrective actions, removals, and design changes related to medical devices. Additionally, she scrutinizes the documentation of user needs in design input requirements and the management of audit actions, specifically related to medical device reporting (MDR). Contamination control, especially in the context of surgical instruments and intrasurgical cleaning, is another key area of emphasis for her.