Manisha Gokuli serves as a Regulatory Affairs Consultant at Immucor/Werfen North America, where she leverages her extensive expertise in navigating the complex regulatory landscape of the healthcare and medical device industry. With a strong focus on pre-market submissions, including FDA 510(k) and PMA applications, Manisha...
Manisha Gokuli serves as a Regulatory Affairs Consultant at Immucor/Werfen North America, where she leverages her extensive expertise in navigating the complex regulatory landscape of the healthcare and medical device industry. With a strong focus on pre-market submissions, including FDA 510(k) and PMA applications, Manisha plays a pivotal role in developing regulatory strategies that ensure compliance and facilitate the timely introduction of innovative electromechanical devices to the market. Her proficiency in post-market product surveillance engineering allows her to monitor device performance and safety, ensuring that any potential issues are addressed proactively through effective corrective and preventive action (CAPA) plans.
Currently, Manisha is engaged in key projects that involve conducting comprehensive gap assessments and authoring Investigational Device Exemption (IDE) applications for in vitro diagnostic (IVD) devices that incorporate sophisticated software components. Her adeptness in human factors engineering assessment enables her to create robust usability assessments and reports, which are critical for demonstrating the safety and effectiveness of medical devices. Additionally, her experience with FDA interactions, including Pre-Sub and Q-Sub submissions, positions her as a valuable asset in fostering transparent communication between regulatory bodies and the organization.
Manisha's skills in research, machine learning, and label design further enhance her ability to contribute to business process improvement initiatives and global product recall strategies. By authoring clinical evaluation reports and managing responses to FDA 483 and warning letters, she ensures that Immucor/Werfen North America maintains its commitment to quality and regulatory excellence, ultimately supporting the health and safety of patients across the globe.
