WASHINGTON, March 1, 2016 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading medical device consulting firm and clinical research organization to the medical device industry that integrates five business value creators regulatory, reimbursement, clinical research, compliance and quality assurance, has hired David McGurl, former Food and Drug Administration (FDA) Premarket Senior Lead Reviewer, to join its regulatory team as a Director.
“MCRA’s growth is attributed to the talented and experienced team that has been built and we are committed to meeting the complexities of today’s challenging healthcare environment,” said Mr. David Lown, General Manager of MCRA.
Prior to joining MCRA, Mr. McGurl served as a FDA Premarket Senior Lead Reviewer of medical devices in one of the Orthopedic Joints Branches (Joint Fixation Devices Branch Two) in the Office of Device Evaluation. Mr. McGurl brings to the firm extensive regulatory experience from his seven years at the FDA in various roles, including his roles as Acting Branch Chief for the Joint Fixation Devices Branch One and Acting Branch Chief for the Orthopedic Joint Devices Branch. Further, he served as lead reviewer on many complex total joint and trauma technologies. Mr. McGurl’s leadership and experience included leading a staff of professionals engaged in the scientific review of Investigational Device Exemptions (IDE), Premarket Approvals (PMA) and 510(k) submissions. In his new role at MCRA, Mr. McGurl will be responsible for strategic regulatory planning, FDA regulatory submissions and client regulatory advisory services.
Mr. McGurl said, “I am honored to join a talented, dynamic firm where I can leverage my FDA experience and biomedical engineering background to assist MCRA’s clients in planning and obtaining regulatory clearances and approvals for their medical device technologies.”
MCRA employs over 50 team members managed by an executive team that has over 150 years of combined experience. MCRA has provided its services to over 500 medical device, biologic and musculoskeletal clients since its inception in 2004.
Mr. Lown added, “MCRA has been very successful in helping clients with their FDA interactions in a data-centric and orthopedic indication-specific manner. We are pleased to have Mr. McGurl join MCRA and assist our industry clients in continuing the advancement of technology innovation for surgeons and patients.”
About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the medical device industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creation initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY.
SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC