WASHINGTON, Nov. 19, 2019 /PRNewswire/ — MCRA, LLC is a leading medical device advisory firm and clinical research organization (CRO) that integrates regulatory, clinical research, reimbursement, compliance and quality assurance in a coordinated manner to assist companies in bringing new technologies and products to the commercial market. We are pleased to announce the expansion of our cardiovascular and digital health franchise through the hiring of Nicole Goodsell Batista, as an Associate Director, Regulatory Affairs.
Nicole joined MCRA from the US Food and Drug Administration, where she most recently served as Assistant Director of the External Heart Rhythm and Rate Device Team for the Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices. In this position, Nicole provided leadership and oversight to a multidisciplinary team responsible for reviewing a variety of cardiac diagnostic devices including, however not limited to, Automatic External Defibrillators (AED), Implantable Cardiac Monitors (ICM), wearable cardiac monitors (e.g., Holter monitors and patch devices), 12-lead ECGs, multi-parameter patient monitors, and software as a medical device (SaMD) such as digital health wearable technology, arrhythmia detection algorithms, and clinical decision support algorithms. Additional areas of therapeutic experience include devices for coronary and peripheral artery disease.
Nicole has extensive knowledge of cardiovascular and digital health medical device regulations and regulatory pathways to drive a device from conception to market. She provided leadership and oversight for Q-submissions, IDE, 510(k), Breakthrough Designation Request, and PMA regulatory submissions. Further, she contributed to management-level device policy implementation discussions. Notably, Nicole participated in the testing and development of the Digital Health Precertification Program, including the Streamlined Review Program and the Excellence Appraisal process. Nicole also contributed to authoring several FDA Guidance Documents including however not limited to 1) Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling, 2) Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions, and 3) Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations. In addition to FDA Guidance Documents, Nicole played an active role in developing and revising various internationally recognized standards in association with TC150/SC2.
David Lown, MCRA’s President said, “We are honored Nicole has joined MCRA. Her experience will strengthen MCRA’s first-in-class team, which I believe is the best globally.”
Nicole said, “It is a privilege to join such an accomplished team of regulatory advisors. In my new role at MCRA, I am particularly excited about the opportunity to be exposed to and work closely with MCRA’s integrated philosophy of delivering coordinated advice for regulatory, clinical, quality assurance, and reimbursement and market access. I am looking forward to working with this extremely talented and experienced team of co-workers all dedicated to being best in class experts to provide a holistic approach to successfully bring new and innovative cardiovascular and digital health technologies to market.”
About MCRA, LLC: Founded in 2004, MCRA is a leading Clinical Research Organization (CRO) and advisory firm. MCRA’s value contribution rests within in its industry experience at integrating five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance to provide a dynamic, market leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics and in vitro diagnostic (IVD) devices.
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