Ms. Michelle McDonough joined MCRA in January 2009 and is responsible for drafting, reviewing, and strategizing US and international regulatory submissions including 510(k)s, PMAs, IDEs, Pre-Submissions, Technical Documentation, and Clinical Evaluation Reports, as well as, the management, design, and implementation of pre- and post-market clinical studies. Michelle has been a leading team member in assisting clients in remediating files to meet the new European medical device guidelines.
Michelle received her Bachelor in Science at Clemson University in Biochemistry and her Master in Science at Clemson University in Bioengineering with a focus in cartilage repair procedures in the knee.
Prior to joining MCRA, Michelle interned for the Orthopedic Research Foundation of the Carolinas (now known as the Hawkins Foundation). There she assisted the Foundation with the ongoing clinical research conducted in conjuction with the Steadman-Hawkins Clinic of the Carolinas.
Additionally, Michelle reviews company design history files, labeling, and clinical protocols for regulatory compliance, performs due diligence reviews of devices, designs and reviews pre-clinical and animal testing for device companies, develops initial and continuing review submissions for IRB approval, and oversees data management of clinical projects.